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FDA Warning Letters, 483s and Recalls: July 2022

FDA enforcement records dated July 2022: 26 warning letters outside tobacco (plus 14 tobacco letters), 47 OAI inspections and 127 Class I recalls. FDA publishes some records weeks after their date, so recent months can still grow.

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Warning letters

A warning letter is FDA's formal notice that a firm has significant violations. Company names link to the letter on fda.gov. Tobacco retailer letters are counted above but not listed.

Date	Company	Issuing office	Subject
Jul 29, 2022	Chaur Fong Inc. Dba 888 Food Company	Office of Human and Animal Food Operations – West Division 5	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Jul 29, 2022	Deggeh Foods, Inc.	Office of Human and Animal Food Operations East – Division 1	Unapproved New Drugs/Misbranded
Jul 28, 2022	EH Maldonado And Company	Division of Southwest Imports	Foreign Supplier Verification Program (FSVP)
Jul 28, 2022	The Royal Ice Cream Company Inc.	Office of Human and Animal Food Operations East – Division 1	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes
Jul 28, 2022	Vitti Labs, LLC	Office of Biological Products Operations – Division 2	Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Jul 27, 2022	Dairy Feeds, Inc.	Division of Human and Animal Food Operations East IV	CGMP/Animal Food/Adulterated
Jul 27, 2022	Sagent Pharmaceuticals, Inc.	Division Pharmaceutical Quality Operations I	CGMP/Drugs/Adulterated
Jul 25, 2022	Bacocas Enterprises Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
Jul 22, 2022	Muscle Feast, LLC	Office of Human and Animal Foods – East 5	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
Jul 21, 2022	Cantoro Food Market	Division of Northern Border Imports	Foreign Supplier Verification Program (FSVP)
Jul 21, 2022	Jose Miguel Gutierrez Salas	Center for Drug Evaluation and Research \| CDER	Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated/Failure to Register and List
Jul 20, 2022	Guangzhou Orchard Aromatherapy & Skin Care Co., Ltd.	Center for Drug Evaluation and Research \| CDER	Refusal to Provide Access to and Copying of Records
Jul 19, 2022	DSP Skin Care LLC	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Jul 18, 2022	Jost Chemical Co.	Division of Pharmaceutical Quality Operations III	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Jul 14, 2022	Daniel Fred Goodman, M.D./Goodman Eye Center	Center for Drug Evaluation and Research \| CDER	Bioresearch Monitoring Program/Institutional Review Board (IRB)
Jul 12, 2022	NatureLab Corp.	Division of Pharmaceutical Quality Operations II	CGMP/Dietary Supplement/Adulterated
Jul 12, 2022	Zyno Medical LLC	Office of Medical Devices and Radiological Health Operations Div. 1 East	CGMP/QSR/Medical Devices/Adulterated
Jul 8, 2022	Custom Research Labs Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
Jul 6, 2022	Elite Supplement Center LLC And Elite Training Facility LLC	Center for Drug Evaluation and Research \| CDER	Finished Pharmaceuticals/Unapproved New Drug
Jul 5, 2022	Bolive, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
Jul 5, 2022	Living Foods LLC	Office of Human and Animal Food- West Division II	Unapproved New Drugs/Misbranded
Jul 5, 2022	Transworld International Trading Corp.	Division of Northeast Imports	Foreign Supplier Verification Program (FSVP)
Jul 1, 2022	1Am USA Incorporated Dba Pleasure Products USA	Center for Food Safety and Applied Nutrition (CFSAN)	Internet Marketing of Unapproved and Misbranded Drugs
Jul 1, 2022	MKS Enterprise, LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Interstate Commerce/Food/Adulterated
Jul 1, 2022	Shopaax.Com	Center for Food Safety and Applied Nutrition (CFSAN)	Interstate Commerce/Food/Adulterated
Jul 1, 2022	Thirsty Run LLC / US Royal Honey LLC	Center for Food Safety and Applied Nutrition (CFSAN)	Internet Marketing of Unapproved and Misbranded Drugs

OAI inspections

OAI (Official Action Indicated) means FDA recommends regulatory and/or administrative action after the inspection. Facility names link to the facility's FDA record.

Date	Facility	Product type	Country
Jul 29, 2022	AnazaoHealth Corporation	Drugs	United States
Jul 29, 2022	OFP Ingredients LLC	Food/Cosmetics	United States
Jul 28, 2022	Fisher Pharmaceuticals Ltd.	Drugs	Israel
Jul 28, 2022	Luce Enterprises LLC	Food/Cosmetics	United States
Jul 28, 2022	Stormberg Foods LLC	Veterinary	United States
Jul 27, 2022	Ultra Chem Labs Corp	Drugs	United States
Jul 26, 2022	Dental Technologies, Inc.	Devices	United States
Jul 26, 2022	K & K Distribution, Inc.	Food/Cosmetics	United States
Jul 22, 2022	Lucero Produce II Corp	Food/Cosmetics	United States
Jul 22, 2022	Nortec Quimica SA	Drugs	Brazil
Jul 22, 2022	Tugusto Foods, Inc.	Food/Cosmetics	United States
Jul 21, 2022	Bootstrap Runners LLC	Tobacco	United States
Jul 21, 2022	GETSCH+HILLER MEDIZINTECHNIK GmbH	Devices	Germany
Jul 21, 2022	Gobwa Exotic Imports Inc	Food/Cosmetics	United States
Jul 21, 2022	Hamilton Medical AG	Devices	Switzerland
Jul 21, 2022	Kimera Labs Inc	Biologics	United States
Jul 21, 2022	PEPE'S FOODS INC	Food/Cosmetics	United States
Jul 21, 2022	Ralco S.R.L.	Devices	Italy
Jul 21, 2022	U.S. Continental Marketing, Inc.	Drugs	United States
Jul 19, 2022	Caeser LLC	Food/Cosmetics	United States
Jul 18, 2022	Auto-Chlor System LLC	Drugs	United States
Jul 18, 2022	Golden Bridge Gourmet, Inc.	Food/Cosmetics	United States
Jul 15, 2022	El Gordo Spices, LLC	Food/Cosmetics	United States
Jul 15, 2022	Herbal Vitality, Inc	Food/Cosmetics	United States
Jul 15, 2022	HP Industries Inc	Tobacco	United States
Jul 15, 2022	Tropical Seas, Inc.	Drugs	United States
Jul 14, 2022	Apollo Import Export Inc.	Food/Cosmetics	United States
Jul 14, 2022	Pure Ground Ingredients, Inc.	Food/Cosmetics	United States
Jul 13, 2022	ARYZ Trading LLC	Food/Cosmetics	United States
Jul 13, 2022	Rip It Vapors	Tobacco	United States
Jul 12, 2022	All In One Global African Family Market LLC	Food/Cosmetics	United States
Jul 11, 2022	Nature's Way Farms, LLC	Food/Cosmetics	United States
Jul 8, 2022	Aizu Olympus Co., Ltd.	Devices	Japan
Jul 8, 2022	Happy Sprout Inc.	Food/Cosmetics	United States
Jul 8, 2022	Kari Gran Inc.	Drugs	United States
Jul 8, 2022	KVK Tech, Inc.	Drugs	United States
Jul 8, 2022	Medical Technical Gases, Inc.	Drugs	United States
Jul 8, 2022	PREMIER NUTRA PHARMA Inc.	Drugs	United States
Jul 8, 2022	Robert J. Hayashi, MD	Drugs	United States
Jul 8, 2022	ZULAND DISTRIBUTOR CORP	Food/Cosmetics	United States
Jul 6, 2022	Mead Johnson & Company, LLC	Food/Cosmetics	United States
Jul 6, 2022	Wintech Medipro LLC	Devices	United States
Jul 5, 2022	Pinnacle Labs International, Inc.	Food/Cosmetics	United States
Jul 5, 2022	RoyalVibe Health Ltd.	Devices	United States
Jul 1, 2022	AB Mauri Foods, Inc	Food/Cosmetics	United States
Jul 1, 2022	Calapaz Corp.	Food/Cosmetics	United States
Jul 1, 2022	Centrient Pharmaceuticals India Private Limited	Drugs	India

Most-cited Form 483 sections

The CFR sections FDA investigators cited most often in inspections that ended this month.

CFR section	Observation	Citations
21 CFR 1.502(a)	Develop FSVP	71
21 CFR 117.35(a)	Sanitary operations - Plant sanitation	17
21 CFR 117.80(c)	Manufacturing, processing, packing, holding - Controls	16
21 CFR 1.504(b)(1)	Hazard analysis biological, chemical, physical	16
21 CFR 117.135(a)(1)	Sanitation preventive controls - Implement	15
21 CFR 117.35(c)	Pest control	15
21 CFR 820.100(a)	Lack of or inadequate procedures	15
21 CFR 820.198(a)	Lack of or inadequate complaint procedures	15
21 CFR 117.10	Personnel	14
21 CFR 117.130(a)(1)	Hazard analysis - Identification of hazard	14

Class I recalls

Class I is FDA's most serious recall class: a reasonable chance the product causes serious health problems or death.

Date	Firm	Product type	Reason
Jul 29, 2022	Edgewell Personal Care Brands, LLC	Drugs	Chemical contamination: presence of benzene
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 29, 2022	Kingdom Creamery Of Vermont LLC	Food	Product may be contaminated Listeria monocytogenes.
Jul 22, 2022	Distributor RFR, LLC.	Drugs	Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Lyons Magnus, Inc	Food	Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
Jul 22, 2022	Wismettac Asian Foods, Inc.	Food	Undeclared allergens; wheat and soy.
Jul 21, 2022	Cardiac Assist, Inc	Devices	Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
Jul 21, 2022	Ultra Supplement LLC	Drugs	Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Jul 20, 2022	Getinge Usa Sales Inc	Devices	Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of…
Jul 18, 2022	MKS Enterprise LLC	Food	Undeclared Tadalafil
Jul 15, 2022	Vi-Jon, LLC	Drugs	Microbial contamination of non-sterile products.
Jul 15, 2022	Vi-Jon, LLC	Drugs	Microbial contamination of non-sterile products.

Showing the latest 100 of 127.

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