Company Inspection Histories

Facility-by-facility FDA inspection records for named manufacturers: every 483, warning letter and classification, with what followed.

Bachem FDA inspection history: 37 FDA inspections at Torrance, Vista, Bubendorf and Vionnaz, 16 ending in a Form 483, with both May 2026 US inspections classified VAI.

Bachem FDA inspection history: Torrance, Vista and every Form 483

The FDA inspection record of Bachem, the peptide and oligonucleotide manufacturer: four facility records in California and Switzerland, 37 inspections from 2001 to 2026, 16 ending with a Form 483. Each facility's history, the two May 2026 inspections at Torrance and Vista and their VAI classifications, what the one public Form 483 cites, the investigators on the record, and what a supplier file on Bachem should hold.

Torrent Pharmaceuticals FDA inspection history cover: 24 of 40 FDA inspections across eight Torrent facilities ended with a Form 483, with the 2019 Indrad warning letter closed out on September 4, 2024.

Company Inspection Histories

Torrent Pharmaceuticals FDA inspection history: Indrad, Dahej and every Form 483

The FDA inspection record of Torrent Pharmaceuticals: eight Torrent facility records in India and the US, 40 inspections and 24 ending with a Form 483. What the 2019 Indrad warning letter cited, how the Indrad, Dahej, Pithampur, Visakhapatnam and Bileshwarpura records read facility by facility, the citations FDA repeats across the group, and where each facility stands in November 2026.

Gland Pharma FDA inspection history and the Dundigal Form 483 of October 2026

Company Inspection Histories

Gland Pharma FDA inspection history: the Dundigal 483, every facility and Cenexi

The FDA inspection record of Gland Pharma and its Cenexi subsidiary: nine facility records in India, France and Belgium, 48 inspections, 30 ending with a Form 483. What Gland disclosed about the October 2026 Form 483 at the Dundigal formulation facility in Hyderabad, what is not public yet, each facility's record, the sterile-processing citation FDA repeats across the group, and what happens next.

Granules India FDA inspection history and the Gagillapur Form 483 of October 2026

Company Inspection Histories

Granules India USFDA Gagillapur inspection: 11 observations and the full FDA record

The October 2026 USFDA inspection of Granules India's Gagillapur finished dosage facility ended with a Form 483 listing 11 observations. What Granules disclosed, how the shares moved, what happens next, the February 2025 warning letter it follows, and the full FDA record across ten Granules facility records: 41 inspections, 23 ending with a Form 483, including ten at Granules Pharmaceuticals Inc. in Chantilly, Virginia.

Reliance Life Sciences Warning Letter

Atlas

Company Inspection Histories

Reliance Life Sciences FDA warning letter 2026: Navi Mumbai data integrity, aseptic practice and the 483s behind it

FDA's drug center sent Reliance Life Sciences a warning letter dated August 18, 2026 for its Rabale, Navi Mumbai facility. This piece covers the two violations, the February 2026 inspection and Form 483 behind them, the recall and Import Alert 66-40 that came first, the facility's 11 FDA inspections and 7 Form 483s in Atlas, and how the findings compare with other Indian drug facilities.

Eurofins FDA Warning Letter

Atlas

Company Inspection Histories

Eurofins FDA warning letter 2026: microbial data integrity at a contract testing lab

FDA's drug center sent Eurofins SF Analytical Laboratories a warning letter dated October 6, 2026 for incomplete microbiology data at its Horsham, Pennsylvania contract testing laboratory. This piece covers the three violations, the 2022 and 2026 Form 483s behind them, the inspection record of 71 Eurofins facility records in Atlas, how often 22 recent contract lab 483s cite data integrity sections, and what a sponsor should check at its own contract lab.

Baxter FDA Warning Letter 2026

Atlas

Company Inspection Histories

Baxter FDA warning letter 2026: Round Lake, the four violations, and the 483s behind them

FDA's drug center sent Baxter a warning letter dated September 29, 2026 for its Round Lake, Illinois sterile injectables facility. This piece covers what the letter cites, the March to April 2026 inspection and Form 483 behind it, the earlier 483s at Round Lake, and the Form 483 record across 47 Baxter facility records in Atlas.

Mylan Viatris India FDA Record

Atlas

Company Inspection Histories

Mylan Nashik and Viatris India: FDA inspection history, 483s and warning letters

The FDA inspection record of Mylan Laboratories Limited, the Viatris company, in India: nine facility records, 57 inspections, 35 ending with a Form 483. What FDA cited at Nashik in May 2024, the 2017 Nashik warning letter and its 2018 closeout, the December 2024 warning letter and Import Alert 66-40 at the Indore facility in Pithampur, and the regulations FDA cites most across Mylan's Indian sites.

Regeneron FDA Form 483 in 2026: East Greenbush inspection and the CRLs tied to a third-party filler

Company Inspection Histories

Regeneron FDA Form 483 in 2026: East Greenbush, Rensselaer and the filler CRLs

What is public about the January 2026 Form 483 at Regeneron's East Greenbush, New York facility, the inspection record of five Regeneron facilities in Atlas (39 inspections, 13 ending in a Form 483), the citations FDA has written at Rensselaer, and the July and October 2025 complete response letters that FDA tied to an inspection of the third-party filler Catalent Indiana.

Hetero Labs FDA inspections: 34 Form 483s in 54 inspections across Hetero facilities

Company Inspection Histories

Hetero Labs FDA inspection history: every unit, every 483, and where things stand

A unit-by-unit record of FDA inspections at Hetero Labs and Hetero Drugs facilities in India and the US: 54 inspections, 34 Form 483 outcomes, the citations FDA repeats, the 2017 Unit V warning letter and its 2022 closeout, the clean 2025 inspection at Vemagal, and the September 2025 inspections at Unit IX and Chinateenarla.

Olympus FDA Warning Letter 2026

Atlas

Company Inspection Histories

Olympus FDA warning letter 2026: the six facilities, the 483s behind it, and the import alert

FDA's warning letter CMS 729208 to Olympus, dated October 7, 2026 and posted October 20, cites 12 violations at six device facilities. On October 20 FDA also added five Japan-made endoscope models to import alert 89-04. This piece lays out the letter, the late-2025 Form 483s behind it, the investigators, each facility's history, and what the import alert means for hospitals and device quality teams.

Fresenius FDA warning letters 2026: what the Ogden and Melrose Park letters say, and the 483s behind them

Company Inspection Histories

Fresenius Kabi FDA warning letter 2026: Melrose Park, the Ogden letter, and the 483s behind them

Two Fresenius facilities received FDA warning letters within four weeks of each other in 2026. This piece explains what the Ogden, Utah and Melrose Park, Illinois letters cite, the Form 483s and inspections that preceded them, the group's wider enforcement record, and what the two cases have in common.

KVK-Tech FDA Warning Letters.

Atlas

Company Inspection Histories

KVK-Tech FDA warning letters: the 2020 letters, the 483s behind them and what followed

FDA sent KVK-Tech two warning letters in 2020: February 11 for test methods, investigations and lab data controls at 110 Terry Drive, and October 8 for cleaning validation and batch records at 100 Campus Drive. This piece sets the letters side by side, lays out the company's full inspection and Form 483 record from 2008 to 2025, and covers the 2021, 2022 and 2025 Form 483s and the 2024 DOJ resolution that followed.

Unexo's 12 FDA Inspection Findings.

Atlas

Company Inspection Histories

Unexo's Operations Questioned as FDA Lists 12 Compliance Issues

Unexo, an over-the-counter drug manufacturer, faced FDA scrutiny during a two-week inspection in May 2024. Investigators Nicole Knowlton and Kellia Hicks documented 12 observations, from missing batch records to a hole in the ceiling of the IPQA area.