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FDA Warning Letters, 483s and Recalls: March 2020

FDA enforcement records dated March 2020: 0 warning letters outside tobacco, 37 OAI inspections and 22 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
Mar 31, 2020Chicago Indoor Garden, Inc.Food/CosmeticsUnited States
Mar 23, 2020NexCaps,Inc.Food/CosmeticsUnited States
Mar 21, 2020La Sonorense, Inc.Food/CosmeticsUnited States
Mar 20, 2020CSB Nutrition CorporationFood/CosmeticsUnited States
Mar 20, 2020Pollman's Bake Shops, Inc.Food/CosmeticsUnited States
Mar 20, 2020The Lennox International, IncVeterinaryUnited States
Mar 18, 2020Copoliva Inc.Food/CosmeticsUnited States
Mar 18, 2020Pasha Food Distribution USA, Inc.Food/CosmeticsUnited States
Mar 17, 2020Cosmax USA, CorporationDrugsUnited States
Mar 17, 2020Etai's Food, LLC.Food/CosmeticsUnited States
Mar 17, 2020HNC Products Inc.DrugsUnited States
Mar 17, 2020ROYAL INTERNATIONAL TRADING LLCFood/CosmeticsUnited States
Mar 16, 2020Joyva Corp.Food/CosmeticsUnited States
Mar 16, 2020Walfer CorporationDrugsUnited States
Mar 13, 2020KVK-Tech, Inc.DrugsUnited States
Mar 13, 2020Pharma Nobis LLCDrugsUnited States
Mar 13, 2020Sugiyo USA INCFood/CosmeticsUnited States
Mar 12, 2020Absorb Health LLCFood/CosmeticsUnited States
Mar 12, 2020Calvin Scott & Company, Inc.DrugsUnited States
Mar 11, 2020Light Age, Inc.DevicesUnited States
Mar 10, 2020Coupler LLCDrugsUnited States
Mar 9, 2020Allied Food Products IncFood/CosmeticsUnited States
Mar 9, 2020Diamond Rock Food Imports Inc.Food/CosmeticsUnited States
Mar 9, 2020Lifequest Creations LLCDrugsUnited States
Mar 9, 2020Panther James LLC.Food/CosmeticsUnited States
Mar 7, 2020Solara Active Pharma Sciences LimitedDrugsIndia
Mar 6, 2020Empower Clinic Services LLCDrugsUnited States
Mar 6, 2020LEC Custom Products, Inc.DrugsCanada
Mar 6, 2020Martinez Mexican Produce LlcFood/CosmeticsUnited States
Mar 6, 2020Megafine Pharma (P) LimitedDrugsIndia
Mar 6, 2020Peggy Lawton Kitchens, Inc.Food/CosmeticsUnited States
Mar 6, 2020Rajshree International IncFood/CosmeticsUnited States
Mar 5, 2020Creation Technologies LtdDevicesCanada
Mar 5, 2020Willis Ocean Inc.Food/CosmeticsUnited States
Mar 4, 2020Borinquen Natural LLCFood/CosmeticsUnited States
Mar 4, 2020J&J Distributing Inc.Food/CosmeticsUnited States
Mar 4, 2020Maspeth Wholesale CorpFood/CosmeticsUnited 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)Maintain, follow FSVP54
21 CFR 820.198(a)Lack of or inadequate complaint procedures19
FDCA 501(a)(2)(A)Vermin, production area18
21 CFR 117.145(a)Sanitation Controls Monitoring Proced: Establish Implement15
21 CFR 117.130(a)(1)Hazard Analysis - Identification of Hazard13
21 CFR 117.35(a)Sanitary operations - Plant sanitation13
21 CFR 117.165(b)Sanitation Controls Verif Procedures: Establish Implement11
21 CFR 211.192Written record of investigation incomplete11
21 CFR 820.100(a)Lack of or inadequate procedures11
FDCA 402(a)(4)Records review prior to shipment for slaughter11

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
Mar 26, 2020MIN JIANG FOOD STORE INC DBA KOI KOI TRADINGFoodSalmon has the potential to be contaminated with Listeria monocytogenes.
Mar 24, 2020Smiths Medical ASD Inc.DevicesSpecific Pumps may exhibit intermittent performance in the AILD (Air in Line Detector) function. If an AILD does not sufficiently discern…
Mar 23, 2020Avet Pharmaceuticals, Inc.DrugsFailed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Mar 23, 2020Avet Pharmaceuticals, Inc.DrugsFailed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
Mar 23, 2020LeMaitre Vascular, Inc.DevicesThere has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Mar 20, 2020Tiffany Food Corp.FoodProduct contains undeclared sulfites.
Mar 20, 2020Winter Gardens Quality Foods, Inc.FoodThe product is being recalled for undeclared allergen (Milk).
Mar 16, 2020Dr. Reddy's Laboratories, Inc.DrugsDefective Container: Recall is due to breaking and shattering of ampules upon opening
Mar 16, 2020Mountain Rose Inc. Dba Mountain Rose HerbsFoodSalmonella
Mar 16, 2020Vascular Solutions, Inc.DevicesThe inner lumen of the Langston catheter may separate from the hub during pressure injection.
Mar 16, 2020Y-O Management LLC, Dba Natural Remedy StoreDrugsMarketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the…
Mar 12, 2020Chicago Indoor Garden, Inc.FoodFDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firm's sprouts with an outbreak of E. coli.
Mar 12, 2020Chicago Indoor Garden, Inc.FoodFDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
Mar 12, 2020Chicago Indoor Garden, Inc.FoodFDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
Mar 12, 2020Chicago Indoor Garden, Inc.FoodFDA sample analysis of sprouts was positive for E. coli. FDA traceback and epi associate the firms sprouts with an outbreak of E. coli.
Mar 11, 2020Forest Mushroom Food Inc.FoodCalifornia Department of Public Health collected samples at retail and found Listeria monocytogenes in Enoki mushrooms from Korea
Mar 10, 2020Pero Family Farms CompanyFoodUndeclared allergens of egg and milk due to incorrect label
Mar 6, 2020Dole Fresh Vegetables IncFoodPrivate brand customer received 3 complaints of consumers finding the incorrect master pack (kit with dressing and other toppings) in 12.6…
Mar 6, 2020Hong Bin Foods LLCFoodState of Michigan sampled and tested Enoki Mushrooms and found them to be positive for Listeria monocytogenes.
Mar 3, 2020Vita Food Products, Inc.FoodUndeclared milk
Mar 2, 2020New Capstone, IncFoodThe firm was notified that the labeling does not include the word milk on the ingredient statement
Mar 2, 2020Whole Foods MarketFoodContains undeclared milk

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.