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FDA Warning Letters, 483s and Recalls: November 2021

FDA enforcement records dated November 2021: 21 warning letters outside tobacco (plus 26 tobacco letters), 37 OAI inspections and 153 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
Nov 30, 2021Dental Technologies Inc.Division of Pharmaceutical Quality Operations IIICGMP/QSR/Medical Devices/Adulterated
Nov 29, 2021Sanitor CorporationDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Nov 24, 2021DSAART, LLC. Dba Alpha AestheticsCenter for Devices and Radiological HealthCGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated
Nov 23, 2021DeVilbiss Healthcare LLCOffice of Medical Device and Radiological Health Operations (Division 1)Medical Device Reporting/Misbranded
Nov 23, 2021Hubei Kangzheng Pharmaceutical Co., Ltd.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Adulterated
Nov 23, 2021Induction Therapies, LLCCenter for Devices and Radiological HealthInvestigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
Nov 23, 2021LIV Health LLC Dba INFINIWELL And DEAL Media L.L.C. Dba HARMONIAOffice of Human and Animal Foods Operations‐East VNew Drug/Misbranded
Nov 22, 2021Sarita's Tortilla Factory, IncOffice of Human and Animal Food Operations West Division 3CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
Nov 18, 2021GeroNova Research Inc.Office of Human and Animal Food Operations - West Division 5Internet Marketing of Unapproved and Misbranded Drugs
Nov 18, 2021Invacare CorporationCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Nov 18, 2021Saffron Health SciencesDivision of Human and Animal Food Operations East IINew Drug/Misbranded
Nov 16, 2021Global Medical Production Co LtdCenter for Devices and Radiological HealthCGMP/QSR/Medical Devices/Adulterated
Nov 15, 2021Surgenex LLCOffice of Biological Products Operations – Division 2Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)
Nov 10, 2021Advanced Nutriceuticals, LLC Dba The Guyer Institute Of Molecular MedicineDivision of Pharmaceutical Quality Operations Division IIICompounding Pharmacy/Adulterated Drug Products
Nov 10, 2021California Terra Garden Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
Nov 9, 2021Synaptent, LLCOffice of Human and Animal Food Operations-East 6New Drug/Misbranded
Nov 8, 2021Banner Smoked Fish Inc.Office of Human and Animal Food Operations East – Division 1Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions
Nov 8, 2021Global Sanitizers LLCDivision of Pharmaceutical Quality Operations IVCGMP/Finished Pharmaceuticals/Adulterated
Nov 4, 2021Bionateo Sp. Z.O.O.Center for Drug Evaluation and Research | CDERCGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated
Nov 3, 2021Lempira Distribution LLCDivision of Southeast ImportsForeign Supplier Verification Program (FSVP)
Nov 3, 2021Rainfield Marketing Group, Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)

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
Nov 30, 2021APNA FOODS IMPORTSFood/CosmeticsUnited States
Nov 30, 2021Edge Pharma, LLCDrugsUnited States
Nov 30, 2021Zhang Medical P.C. D/B/A New Hope Fertility CenterBiologicsUnited States
Nov 23, 2021Harvester Foods Corp.Food/CosmeticsUnited States
Nov 19, 2021D&A, Inc.Food/CosmeticsUnited States
Nov 19, 2021Larkin Community Hospital IRBDrugsUnited States
Nov 19, 2021Specialty Process Labs LLCDrugsUnited States
Nov 19, 2021Ultra Seal CorporationDrugsUnited States
Nov 18, 2021Fagron, IncDrugsUnited States
Nov 18, 2021Foundation Vapor LLCTobaccoUnited States
Nov 18, 2021Teahouse Tapioca And Tea Inc.Food/CosmeticsUnited States
Nov 17, 2021Colorful Products CorporationDrugsUnited States
Nov 17, 2021Joyva Corp.Food/CosmeticsUnited States
Nov 17, 2021Miller Milling, LLCFood/CosmeticsUnited States
Nov 16, 2021BEST FIJI KAVA INC.Food/CosmeticsUnited States
Nov 16, 2021Corporacion Avicola Morovis, Inc.Food/CosmeticsUnited States
Nov 16, 2021GLOBAL LC, INCFood/CosmeticsUnited States
Nov 16, 2021KEELER FAMILY FARMS LLCFood/CosmeticsUnited States
Nov 16, 2021Promex Distribution LLCFood/CosmeticsUnited States
Nov 11, 2021Fresh Farms LLCDrugsUnited States
Nov 10, 2021Golden Lab LLCFood/CosmeticsUnited States
Nov 10, 2021Lecs Usa IncFood/CosmeticsUnited States
Nov 10, 2021Purina Animal Nutrition LLCVeterinaryUnited States
Nov 9, 2021Advanced Accelerator Applications USA, Inc.DrugsUnited States
Nov 9, 2021Hindy Import IncFood/CosmeticsUnited States
Nov 9, 2021Philips Respironics, Inc.DevicesUnited States
Nov 8, 2021Sozinho Dairy Inc. #1VeterinaryUnited States
Nov 5, 2021Daniel C. Tarquinio, DODrugsUnited States
Nov 5, 2021Langlinais' Baking CompanyFood/CosmeticsUnited States
Nov 5, 2021Miami UniversityDrugsUnited States
Nov 4, 2021National Chemical LaboratoriesDrugsUnited States
Nov 4, 2021Plastikon Healthcare LLCDrugsUnited States
Nov 4, 2021SterRx, LLCDrugsUnited States
Nov 3, 2021Agropharma Laboratories Inc.DrugsUnited States
Nov 2, 2021Riedstra Dairy LimitedVeterinaryUnited States
Nov 2, 2021Strive Pharmacy Texas LLCDrugsUnited States
Nov 1, 2021Macleods Pharmaceuticals LimitedDrugsIndia

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 FSVP35
21 CFR 117.35(a)Sanitary operations - Plant sanitation20
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard17
21 CFR 820.100(a)Lack of or inadequate procedures14
21 CFR 820.75(a)Lack of or inadequate process validation14
21 CFR 211.192Written record of investigation incomplete13
21 CFR 111.70(e)Specifications - identity, purity, strength, composition12
21 CFR 123.6(b)No HACCP plan12
21 CFR 211.22(d)Procedures not in writing, fully followed12
21 CFR 117.20(b)Plant construction and design9

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
Nov 30, 2021Aroma Release Technologies IncDrugsMarketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Nov 30, 2021Teligent Pharma, Inc.DrugsSuperpotent Drug
Nov 24, 2021International Golden Foods IncFoodpotential contamination with Salmonella
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 23, 2021The Procter & Gamble CompanyDrugsChemical contamination: presence of benzene
Nov 22, 2021Cardiovascular Systems IncDevicesUnder certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may…
Nov 19, 2021American Screening LLCDrugsLabeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Nov 18, 2021Cargill Cocoa & Chocolate, Inc.FoodProduct recalled because of the presence of undeclared peanuts.
Nov 17, 2021Blistex IncDrugsChemical contamination: Presence of benzene
Nov 17, 2021J F C International IncFoodManufacturer notified US supplier that powdered shrimp stock did not declare fish (hydrolyzed protein that contains bonito, sardine and…
Nov 17, 2021Sandoz IncDrugsTemperature Abuse; temperature excursion during shipping
Nov 16, 2021Five Star Gourmet Foods, Inc.FoodInternal product label review discovered that wheat is not declared as an ingredient or allergen in Cranberry Walnut salad. Flatbread…
Nov 16, 2021Mountain Meadow Herbs, Inc.FoodProduct bottle has potential to become pressurized over time. When consumer opens a bottle, the cap, capsules, and product powder could be…
Nov 15, 2021Datascope Corp.DevicesFirm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components…
Nov 15, 2021Datascope Corp.DevicesFirm is initiating a correction due to the possibility of fluid ingress. Fluid entering the device may short various electronic components…
Nov 15, 2021The Fillo Factory Inc.FoodUndeclared milk allergen
Nov 11, 2021Medtronic Navigation, Inc.DevicesCranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the…
Nov 11, 2021Oregon Lox CompanyFoodListeria monocytogenes.
Nov 11, 2021Oregon Lox CompanyFoodListeria monocytogenes.
Nov 11, 2021Oregon Lox CompanyFoodListeria monocytogenes.
Nov 10, 2021ELLENOS REAL GREEK YOGURT - SEATFoodUndeclared Egg.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk and soy.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared milk.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified that the product contains undeclared shellfish.
Nov 9, 2021NutraCap Labs LLCFoodDuring an FDA investigation the firm was notified of the product contains undeclared milk.

Showing the latest 100 of 153.

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