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FDA Warning Letters, 483s and Recalls: October 2021

FDA enforcement records dated October 2021: 25 warning letters outside tobacco (plus 53 tobacco letters), 26 OAI inspections and 77 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.

DateCompanyIssuing officeSubject
Oct 29, 2021Marquis Worldwide Specialty, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 25, 2021Maribel's Sweets, Inc.Office of Human and Animal Food Operations - East Division 1CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Oct 22, 2021Applied Health Solutions, Inc.Office of Human and Animal Food Operations - Division IV WestNew Drug/Misbranded
Oct 22, 2021DongBang Cosmetics Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Oct 22, 2021ITC Global Trading Inc.Division of Southwest Imports Compliance BranchForeign Supplier Verification Program (FSVP)
Oct 21, 2021Dominant Nutrition LLC Formerly 8 Weeks Out LabsOffice of Human and Animal Foods WestDietary Supplement/Adulterated
Oct 21, 2021Golden Medal Mushroom Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 21, 2021Green Food Ingredients, LLCDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Oct 20, 2021Bartlett Cooperative Association Bartlett Feed MillOffice of Human and Animal Foods West Division IICGMP/Medicated Feeds/Adulterated
Oct 20, 2021CellEra LLCOffice of Medical Device and Radiological Health Division 1 – EastCGMP/QSR/Medical Devices/Adulterated
Oct 20, 2021Fitsum Ghebremichael AmareDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 19, 2021Bella Rosa Distribution IncDivision of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Oct 19, 2021Jule's FoodsOffice of Human and Animal Food Operations- West Division 5CGMP Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Oct 15, 2021Empower Clinic Services, LLC Dba Empower PharmacyOffice of Pharmaceutical Quality Operations, Division IICompounding Pharmacy/Adulterated Drug Products
Oct 15, 2021JD's Market Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 14, 2021Joseph A. Zadra, M.D.Center for Drug Evaluation and Research | CDERClinical Investigator
Oct 14, 2021New Green Nutrition, Inc.Center for Drug Evaluation and Research | CDERFinished Pharmaceuticals/Unapproved New Drug/Misbranded
Oct 13, 2021Organa International Corp.Office of Human and Animal Food Operations Division West 4Unapproved New Drugs/Misbranded
Oct 13, 2021Quicksilver ScientificOffice of Human and Animal Food Operations Division West 4New Drug/Misbranded
Oct 8, 2021AriBio H&B Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated/Misbranded
Oct 7, 2021Notarika, S.A. De C.V.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Oct 5, 2021Owlet Baby Care, Inc.Center for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Oct 1, 2021BN Trading, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
Oct 1, 2021Kim Nhung Marketplace IncDivision of West Coast ImportsForeign Supplier Verification Program (FSVP)
Oct 1, 2021Smiths Medical ASD Inc.Center for Devices and Radiological HealthMedical Device Reporting/Misbranded

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.

DateFacilityProduct typeCountry
Oct 29, 2021Adarsh Daswani, M.D.DrugsUnited States
Oct 29, 2021AniCell Biotech, LLCVeterinaryUnited States
Oct 29, 2021New Sun IncFood/CosmeticsUnited States
Oct 29, 2021New Vision Pharmaceuticals LLCDrugsUnited States
Oct 29, 2021TG Labs, Inc.DrugsUnited States
Oct 27, 2021Las Dos Californias IncFood/CosmeticsUnited States
Oct 27, 2021Syfrett Feed Company, Inc.VeterinaryUnited States
Oct 25, 2021Lartigue's Seafood Inc.Food/CosmeticsUnited States
Oct 22, 2021NatureLab Corp.Food/CosmeticsUnited States
Oct 22, 2021Xinxiang Tuoxin Pharmaceutical Co. LtdDrugsChina
Oct 21, 2021Ulrich FarmsVeterinaryUnited States
Oct 19, 2021Aire-Master Of America IncDrugsUnited States
Oct 19, 2021Northeast Seafood Products, IncorporatedFood/CosmeticsUnited States
Oct 15, 2021A & M MILLER LLCFood/CosmeticsUnited States
Oct 15, 2021Swabplus, L.P.DrugsUnited States
Oct 15, 2021Verde Cosmetic Labs, LLCDrugsUnited States
Oct 14, 2021Schreiber Foods, Inc.Food/CosmeticsUnited States
Oct 13, 2021Nice-Pak Products, LLCDrugsUnited States
Oct 12, 2021SUNNY SKY PRODUCTSFood/CosmeticsUnited States
Oct 8, 2021Absolute Vapor Lounge, LLCTobaccoUnited States
Oct 8, 2021InfuScience, Inc.DrugsUnited States
Oct 8, 2021Pet Center IncVeterinaryUnited States
Oct 7, 2021Expert Chemical Analysis, Inc.DrugsUnited States
Oct 6, 2021DLG Naturals, Inc.Food/CosmeticsUnited States
Oct 6, 2021Greenhead Lobster Products LLCFood/CosmeticsUnited States
Oct 5, 2021Greenbrier International, IncDrugsUnited States

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 820.100(a)Lack of or inadequate procedures19
21 CFR 123.6(b)No HACCP plan15
21 CFR 123.11(b)Sanitation monitoring documentation13
21 CFR 211.192Quality control unit review of records13
21 CFR 820.198(a)Lack of or inadequate complaint procedures13
21 CFR 117.35(a)Sanitary operations - Plant sanitation11
21 CFR 1.502(a)Develop FSVP11
21 CFR 211.22(d)Procedures not in writing, fully followed10
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures9
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard8

Class I recalls

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

DateFirmProduct typeReason
Oct 29, 2021Dole Fresh Vegetables IncFoodThe Georgia Department of Agriculture sampled and found Listeria monocytogenes in Dole Garden Salad. Product was packed under 3 additional…
Oct 29, 2021Dole Fresh Vegetables IncFoodThe Georgia Department of Agriculture sampled and found Listeria monocytogenes in Dole Garden Salad. Product was packed under 3 additional…
Oct 29, 2021Dole Fresh Vegetables IncFoodThe Georgia Department of Agriculture sampled and found Listeria monocytogenes in Dole Garden Salad. Product was packed under 3 additional…
Oct 29, 2021Dole Fresh Vegetables IncFoodThe Georgia Department of Agriculture sampled and found Listeria monocytogenes in Dole Garden Salad. Product was packed under 3 additional…
Oct 28, 2021MARY RUTH ORGANICSFoodInternal testing found the presence of Pseudomonas aeruginosa in the product.
Oct 28, 2021Pier-C Produce, Inc.FoodWhite onions potentially contaminated with Salmonella.
Oct 26, 2021Simply Delicious, Inc.FoodAlmond Butter Bars contain undeclared peanuts.
Oct 26, 2021VIRGIN SCENT INCDrugsChemical Contamination: presence of benzene, acetaldehyde, and acetal.
Oct 25, 2021Cedar's Mediterranean Foods, Inc.FoodMay contain undeclared tree nuts (pine nuts)
Oct 25, 2021POTANDON PRODUCE LLCFoodSalmonella Oranienburg. Products are supplied by Keeler Family Farm.
Oct 25, 2021POTANDON PRODUCE LLCFoodSalmonella Oranienburg. Products are supplied by Keeler Family Farm.
Oct 24, 2021JF Palmer & Sons ProduceFoodPotential to be contaminated with Salmonella
Oct 24, 2021JF Palmer & Sons ProduceFoodPotential to be contaminated with Salmonella
Oct 24, 2021JF Palmer & Sons ProduceFoodPotential to be contaminated with Salmonella
Oct 23, 2021Taylor Farms Tennessee, Inc.FoodPositive Listeria monocytogenes in random sampling.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021HELLOFRESH USFoodProducts contain onions purchased from ProSource and associated with a Salmonella Oranienburg outbreak.
Oct 22, 2021KEELER FAMILY FARMSFoodPotential contamination with Salmonella Oranienburg in onions from Chihuahua, Mexico.
Oct 22, 2021KEELER FAMILY FARMSFoodPotential contamination with Salmonella Oranienburg in onions from Chihuahua, Mexico.
Oct 22, 2021KEELER FAMILY FARMSFoodPotential contamination with Salmonella Oranienburg in onions from Chihuahua, Mexico.
Oct 22, 2021POTANDON PRODUCE LLCFoodPotential to be contaminated with Salmonella Oranienburg.
Oct 22, 2021POTANDON PRODUCE LLCFoodPotential to be contaminated with Salmonella Oranienburg.
Oct 22, 2021POTANDON PRODUCE LLCFoodPotential to be contaminated with Salmonella Oranienburg.
Oct 21, 2021Bix Produce Company LLCFoodOnions may be contaminated with Salmonella
Oct 21, 2021Brothers Produce Of Dallas IncFoodPotential for onions distributed by the firm to be contaminated with Salmonella
Oct 21, 2021E-Z Spuds IncFoodPotential contamination with Salmonella
Oct 21, 2021Givaudan Flavours CorpFoodPositive Salmonella sp. in product
Oct 21, 2021Hardies Fruit & Vegetable Co., LPFoodPotential to be contaminated with Salmonella
Oct 21, 2021Hardies Fruit & Vegetable Co., LPFoodPotential to be contaminated with Salmonella
Oct 21, 2021Hardies Fruit & Vegetable Co., LPFoodPotential to be contaminated with Salmonella
Oct 21, 2021Onions 52FoodVoluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
Oct 21, 2021Onions 52FoodVoluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
Oct 21, 2021Onions 52FoodVoluntary recall due to possible contamination with Salmonella Oranienburg in onions from Chihuahua Mexico.
Oct 21, 2021Sysco Merchandising And SupplyFoodThe firm distributed onion products which have the potential to be contaminated with Salmonella.
Oct 21, 2021Sysco Merchandising And SupplyFoodThe firm distributed onion products which have the potential to be contaminated with Salmonella.
Oct 21, 2021Sysco Merchandising And SupplyFoodThe firm distributed onion products which have the potential to be contaminated with Salmonella.
Oct 20, 2021Lakeview Farms, LLC.FoodUndeclared Allergen - Egg
Oct 20, 2021ProSource Produce LLCFoodSalmonella Oranienburg.
Oct 20, 2021ProSource Produce LLCFoodSalmonella Oranienburg.
Oct 20, 2021ProSource Produce LLCFoodSalmonella Oranienburg.
Oct 19, 2021MERCK SHARP & DOHME CORPDrugsPresence of Particulate Matter: Identified as Glass Particles
Oct 14, 2021Lumenis, Inc.DevicesUltrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA…
Oct 12, 2021Bryant Ranch Prepack, Inc. Dba BRP PharmaceuticalsDrugsLabeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Oct 12, 2021Teligent Pharma, Inc.DrugsSuperpotent Drug
Oct 7, 2021Nestle Usa IncFoodUndeclared Allergen - Peanuts
Oct 7, 2021Nestle Usa IncFoodUndeclared Allergen - Peanuts
Oct 7, 2021Nestle Usa IncFoodUndeclared Allergen - Peanuts
Oct 7, 2021Nestle Usa IncFoodUndeclared Allergen - Peanuts
Oct 7, 2021Northeast Seafood Products, IncorporatedFoodSeafood and fin fish products potentially contaminated with Salmonella and implicated in illness outbreak
Oct 6, 2021International Sprout Holding Inc.FoodProduct tested positive for Listeria monocytogenes
Oct 5, 2021Kwokcheng Enterprise, Inc. Dba Fullei FreshFoodFirm is voluntarily recalling all lots/codes of bean and soy sprouts in commerce due to the potential for contamination with Listeria…
Oct 2, 2021Greenhead Lobster Products LLCFoodProducts may be contaminated with Listeria monocytogenes.
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021Bayer Healthcare Pharmaceuticals Inc.DrugsChemical Contamination: presence of benzene
Oct 1, 2021ELLUME LTDDevicesDue to a higher rate of false positive test results.

Check one company

See one company's full record with the free FDA compliance check, or search warning letters and Form 483 citations by name.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.