Merck Biodevelopment
Form 483 issued October 14, 2022 · Martillac, France
- Inspection
- Oct 6 – Oct 14, 2022
- Investigators
- Jeanne Fringer· Rong Wang
- Observations
- 10
- Pages
- 7
- FEI number
- 3009563840
In short: On October 14, 2022, FDA issued a Form 483 with 10 observations to Merck Biodevelopment in Martillac, France (FEI 3009563840) after an inspection that ran Oct 6 – Oct 14, 2022. The investigators were Jeanne Fringer and Rong Wang. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
Most cited: 21 CFR 211.160 (2×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to assure adequate control…
- 02
Deviation investigations are…
- 03
Quality Assurance oversight is…
- 04
Your firm’s environmental monitoring (EM) program does not include appropriate measures to monitor, trend…
This inspection in context
Jeanne Fringer
6 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Biodevelopment?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Merck Biodevelopment?
Jeanne Fringer and Rong Wang are named on this Form 483, for the inspection of Oct 6 – Oct 14, 2022. Each investigator has a profile showing what they cite most.
When was Merck Biodevelopment inspected by FDA?
The inspection ran Oct 6 – Oct 14, 2022, and the Form 483 is dated October 14, 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.