[ FDA INSPECTION INTELLIGENCE ]
Where FDA is finding serious problems
4,022
OAI ON FILE · 0.4% RECENT BASE RATE
FDA‑posted inspection classifications (Data Dashboard, latest 2026-07-23). Classifications post weeks to months after an inspection ends, so “recent” means recently classified, not recently inspected; foreign sites are inspected far less often than US ones, so geography maps FDA’s reach, not global quality; and one firm can appear many times across sites and program areas. Read this as signal, not a scoreboard.
HOW INSPECTIONS CLOSE · RECENT WINDOW
NAI No Action Indicated · 3,443 · 76.8%
VAI Voluntary Action Indicated · 1,024 · 22.8%
OAI Official Action Indicated · 18 · 0.4%
Most inspections close clean — NAI is the base rate. OAI is rare, which is exactly why each one below is worth reading.
RECENT OAI CLASSIFICATIONS
2026-06-04
Piquin Y Sabores Distributors LLC
Garland, Texas · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-06-04
Fil-Bay Import, Inc.
Hayward, California · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-05-27
BEAUTY STORE LLC
Kennesaw, Georgia · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-05-20
Eherbs Imports, Inc.
San Diego, California · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-05-20
Balkanica LLC
Clifton, New Jersey · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-05-15
Unither Manufacturing LLC.
Rochester, New York · Drug Quality Assurance
OAIDrugs483 POSTED
2026-05-08
Milchwerke "Mittelelbe" GmbH
Stendal · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-05-08
Milchwerke "Mittelelbe" GmbH
Stendal · Food Composition, Standards, Labeling and Econ
OAIFood/Cosmetics483 POSTED
2026-05-04
M.G.R. Produce, LLC
Houston, Texas · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-04-30
AF Import & Wholesale Co
Houston, Texas · Foodborne Biological Hazards
OAIFood/Cosmetics
2026-04-30
Per Os Biosciences, LLC
Hunt Valley, Maryland · Food Composition, Standards, Labeling and Econ
OAIFood/Cosmetics483 POSTED
2026-04-29
King Farm
Dover, Delaware · Monitoring of Marketed Animal Drugs, Feed, and Devices
OAIVeterinary483 POSTED
2026-04-29
EVER RICH FOODS LLC
Edison, New Jersey · Foodborne Biological Hazards
OAIFood/Cosmetics483 POSTED
2026-04-24
Hanlim Pharm Co. Ltd.
Yongin · Drug Quality Assurance
OAIDrugs483 POSTED
2026-04-24
Fragrance Manufacturing, Inc.
Allentown, Pennsylvania · Drug Quality Assurance
OAIDrugs483 POSTED
2026-04-21
Altaire Pharmaceuticals, Inc.
Aquebogue, New York · Drug Quality Assurance
OAIDrugs483 POSTED
2026-04-17
Shoolin Pharma Chem LLP
Kadi · Drug Quality Assurance
OAIDrugs
2026-04-14
Rohto-Mentholatum (Vietnam) Co., Ltd.
Ho Chi Minh · Drug Quality Assurance
OAIDrugs483 POSTED
2026-04-08
Steribite, LLC
Wooster, Ohio · Compliance: Devices
OAIDevices483 POSTED
2026-04-03
Nutribio, SA
Montauban · Foodborne Biological Hazards
OAIFood/Cosmetics
An OAI classification is FDA’s assessment of inspection findings, not a SPEQ characterization of the firm. Firms appear as dated records with FDA’s own label — SPEQ publishes no risk score or ranking, and an inspection outcome is a moment in time, not a standing verdict.
OAI BY FISCAL YEAR
* current fiscal year — partial, and classifications are still posting; not comparable to closed years.
BY PRODUCT AREA · OAI OVERLAID
† small denominator (<50) — read the count, not a rate.
TOP US STATES BY INSPECTIONS
TOP COUNTRIES BY INSPECTIONS
SOURCE: FDA DATA DASHBOARD · INSPECTIONS_CLASSIFICATIONS · 4,485 RECORDS
Looking up one firm? The Company Dossier joins these inspections to recalls and warning letters. For where establishments are, see the GxP Landscape.
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