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FDA Warning Letters, 483s and Recalls: September 2018

FDA enforcement records dated September 2018: 0 warning letters outside tobacco, 37 OAI inspections and 201 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.

No warning letters outside tobacco are recorded for this month yet.

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
Sep 28, 2018Alpha Feed Mill, IncVeterinaryUnited States
Sep 28, 2018Dong Yuan Technology Co., Ltd.DrugsChina
Sep 28, 2018Hetero Labs LimitedDrugsIndia
Sep 28, 2018Pat's Exotic Beverages, Inc.Food/CosmeticsUnited States
Sep 28, 2018Seiki, Inc.Food/CosmeticsJapan
Sep 27, 2018Asclemed USA Inc.DrugsUnited States
Sep 27, 2018Keshodwala Foods (Unit 1)Food/CosmeticsIndia
Sep 26, 2018Bell-More Labs, Inc.VeterinaryUnited States
Sep 26, 2018Circulatory Technology Inc.DevicesUnited States
Sep 25, 2018Gravel Ridge FarmsFood/CosmeticsUnited States
Sep 25, 2018Marriott, Inc.DevicesUnited States
Sep 24, 2018A1 Top World Products, Inc.Food/CosmeticsUnited States
Sep 24, 2018Grandma's Herbs, Inc.Food/CosmeticsUnited States
Sep 24, 2018UBE Analytical Laboratories, Inc.DrugsUnited States
Sep 21, 2018Campolor, Inc.Food/CosmeticsUnited States
Sep 21, 2018Laboratoires ClarinsDrugsFrance
Sep 20, 2018Ozark Pickle PantryFood/CosmeticsUnited States
Sep 19, 2018Accurate RX Pharmacy Consulting LLCDrugsUnited States
Sep 19, 2018IntegraDose Compounding Services LLCDrugsUnited States
Sep 17, 2018ActiveHerb Technology, IncFood/CosmeticsUnited States
Sep 17, 2018DimcoGray Inc.DevicesUnited States
Sep 14, 2018AMMD Labs, LLCDrugsUnited States
Sep 14, 2018JCB Laboratories LLCDrugsUnited States
Sep 14, 2018Marukyo Co., Ltd.Food/CosmeticsJapan
Sep 14, 2018Pharmatory OyVeterinaryFinland
Sep 13, 2018Biometrics Ltd.DevicesUnited Kingdom
Sep 13, 2018Qualgen, LLCDrugsUnited States
Sep 11, 2018China Farms, Inc.Food/CosmeticsUnited States
Sep 11, 2018Hookah Imports Inc:TobaccoUnited States
Sep 6, 2018Aap Biomaterials, GmbHDevicesGermany
Sep 6, 2018CareFusion 303, Inc.DevicesUnited States
Sep 6, 2018Greenwood Ice CreamFood/CosmeticsUnited States
Sep 5, 2018Pharmasol CorporationDrugsUnited States
Sep 4, 2018Osteotec LimitedDevicesUnited Kingdom
Sep 4, 2018Rauch Polska Sp. Zo.O.Food/CosmeticsPoland
Sep 4, 2018Vinill Inc.Food/CosmeticsUnited States
Sep 1, 2018Vital Laboratories Pvt Ltd Plant IIDrugsIndia

Most-cited Form 483 sections

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

CFR sectionObservationCitations
21 CFR 1.502(a)Develop FSVP72
21 CFR 123.11(b)Sanitation monitoring documentation25
21 CFR 117.80(c)Process Control Measures23
21 CFR 820.100(a)Lack of or inadequate procedures22
21 CFR 211.22(d)Procedures not in writing, fully followed20
FDCA 402(a)(4)System for administration of drugs20
21 CFR 117.35(a)Sanitary operations - Plant sanitation18
21 CFR 117.35(c)Pest control16
21 CFR 820.198(a)Lack of or inadequate complaint procedures15
21 CFR 117.10Personnel14

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
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018La Mexicana LLCFoodPotential Listeria monocytogenes contamination.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.
Sep 28, 2018Working Cow Homemade Inc.FoodProducts may be contaminated with Listeria monocytogenes.

Showing the latest 100 of 201.

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