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FDA Warning Letters, 483s and Recalls: October 2020

FDA enforcement records dated October 2020: 0 warning letters outside tobacco, 7 OAI inspections and 94 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
Oct 28, 2020Santec Chemicals Corp.DrugsUnited States
Oct 27, 2020Sharp Sterile Manufacturing, LLCDrugsUnited States
Oct 27, 2020Sunshine Mills, Inc.VeterinaryUnited States
Oct 21, 2020My Habitat Brands LLCFood/CosmeticsUnited States
Oct 16, 2020Unipack LLCDrugsUnited States
Oct 13, 2020Wismettac Asian Foods, Inc.Food/CosmeticsUnited States
Oct 7, 2020Synapse Biomedical IncDevicesUnited States

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)FSVP assurances20
21 CFR 117.35(a)Sanitary operations - Plant sanitation9
21 CFR 312.60FD-1572, protocol compliance9
21 CFR 123.6(b)No HACCP plan6
21 CFR 117.35(c)Pest control5
21 CFR 117.80(c)Manufacturing, processing, packing, holding - Controls5
21 CFR 1.506(a)(1)Approved supplier procedures - importer established5
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard4
21 CFR 123.11(b)Sanitation monitoring documentation3
21 CFR 123.12(a)(2)Importer verification3

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 28, 2020Lohxa LLCDrugsMicrobial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the…
Oct 28, 2020National Food Trading CorporationFoodPossible contamination with Listeria monocytogenes.
Oct 28, 2020Russ Davis Wholesale, LLCFoodundeclared egg
Oct 27, 2020Sunstar Americas, Inc.DrugsMicrobial Contamination of Non-sterile Products: contamination with Burkholderia lata.
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 27, 2020Whole Foods MarketFoodPotential to contain undeclared egg
Oct 23, 2020Incredible FishFoodUndeclared Allergens: Fish, Egg, and Milk.
Oct 23, 2020Orca Bay Foods LLCFoodUndeclared Wheat and Milk.
Oct 22, 2020COMERCIAL MEXICANAFoodProduct may present a choking hazard.
Oct 22, 2020Cook Inc.DevicesAffected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the…
Oct 16, 2020Starwest Botanicals, IncFoodDirect customer tested product upon receipt and had a positive result for Salmonella.
Oct 14, 2020Hadson (Toko) Trading Co., Inc.FoodProduct is a choking hazard.
Oct 9, 2020B&G Foods North America, IncFoodB&G Foods initiated a recall of Back to Nature Organic Rosemary & Olive Oil Stoneground Wheat Crackers, 6 oz. with a best by date of APR…
Oct 9, 2020Red Monkey Foods IncFoodAn ingredient (parsley) which was repacked into consumer packages and used to manufacture other herb blends tested positive for Salmonella…
Oct 9, 2020Red Monkey Foods IncFoodAn ingredient (parsley) which was repacked into consumer packages and used to manufacture other herb blends tested positive for Salmonella…
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Sauer Brands Inc - SLOFoodPotential Salmonella contamination.
Oct 9, 2020Spring Glen Fresh FoodsFoodUndeclared egg and milk due to mis-labeling.
Oct 8, 2020High Quality OrganicsFoodDirect customer tested organic parsley upon receipt and received a confirmed positive result for Salmonella.
Oct 8, 2020High Quality OrganicsFoodDirect customer tested organic parsley upon receipt and received a confirmed positive result for Salmonella.
Oct 8, 2020High Quality OrganicsFoodDirect customer tested organic parsley upon receipt and received a confirmed positive result for Salmonella.
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Med Shop Total Care Inc.DrugsNon-Sterility
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 5, 2020Meijer Inc./Traffic Dept.Foodpotential risk of Salmonella
Oct 2, 2020Seneca Foods CorporationFoodProduct may be contaminated with Salmonella.
Oct 1, 2020ASHTEL STUDIOS, INC.DrugsLabeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes
Oct 1, 2020Country Fresh Inc.FoodPotential to be contaminated with Listeria monocytogenes

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.