Merck Biodevelopment
Form 483 issued May 24, 2022 · Martillac, France
- Inspection
- May 16 – May 24, 2022
- Investigators
- Chen Sun· Matthew B. Casale· Richard Ledwidge
- Observations
- 3
- Pages
- 3
- FEI number
- 3009563840
In short: On May 24, 2022, FDA issued a Form 483 with 3 observations to Merck Biodevelopment in Martillac, France (FEI 3009563840) after an inspection that ran May 16 – May 24, 2022. The investigators were Chen Sun, Matthew B. Casale and Richard Ledwidge. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviation investigations for visible particles observed in) @) drug substance intermediate manufacturing were inadequate, and the…
- 02
The documentation and written explanation for deviations…
- 03
Temporary changes to normal equipment storage conditions…
This inspection in context
Chen Sun
3 documents · 2019–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in France.
The firmMerck Biodevelopment history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Biodevelopment?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Merck Biodevelopment?
Chen Sun, Matthew B. Casale and Richard Ledwidge are named on this Form 483, for the inspection of May 16 – May 24, 2022. Each investigator has a profile showing what they cite most.
When was Merck Biodevelopment inspected by FDA?
The inspection ran May 16 – May 24, 2022, and the Form 483 is dated May 24, 2022.
How do I get the full Form 483 for Merck Biodevelopment?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.