ANSWERS · 4 OCT 2026

Which FDA warning letters were issued to drug manufacturers for CGMP violations in 2026? List company, date, facility country and the main cited violations (21 CFR 211), with links to the letters.

I found 29 FDA warning letters issued between January and September 2026 to drug manufacturers for CGMP violations under 21 CFR parts 210/211. Kirkman (HTO Nevada) received the first on 27 January and Babikian Healthcare Products the most recent on 21 September. The full table is in the panel document, with company, date, facility country, the main 211 citations and a link to each letter.

What stands out:

Testing of incoming components (211.84) is the most common citation. Most often the firm didn't test each component for identity or didn't check the supplier's certificates of analysis. Two letters went further and cited talc that wasn't tested for asbestos: Zydus (Baddi, India) and PLZ Corp.
Sterile and aseptic failures (211.113(b), 211.42(c)(10), 211.63) appear in the letters to Fareva Amboise (France), Pharmathen (Greece), Excelvision (Fareva), Wizcure, PReye, Fagron Sterile Services, Bio-Medical and Jabil (Pharmaceutics International).
Poor investigations (211.192) drove the letters to Medline, where Bacillus cereus was found in finished product about nine times, and Fresenius Medical Care Ogden, over complaints about leaking Delflex bags. Fresenius was also required to hire a consultant under 211.34.
Data integrity and the quality unit (211.22, 211.194) feature in the letters to Zydus (failing infrared identification results edited to pass), Wizcure (microbial plates replaced), Tentamus India (a contract testing lab) and Ava.
By country: 15 US sites, 6 India, 2 China, and one each in France, Greece and the UK. For the other letters, the country wasn't in the text I read.
Not included in the 29: Henan Lvyuan (China, 26 March) and Shoolin Pharma Chem (18 August) are API makers, so their CGMP findings don't fall under 21 CFR 211. I list them separately in the panel document.

Approach: None of the regulatory datasets I can search holds FDA warning letters, so I used FDA's warning-letter pages on fda.gov. I read search snippets rather than the full letters, so this may not be every 2026 letter, and some entries describe the violation without naming the 211 section.

Sources:

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