Laboratoires Merck Sharp & Dohme Chibret
Form 483 issued January 19, 2016 · Riom, France
- Inspection
- Jan 11 – Jan 19, 2016
- Investigators
- Anita Narula· Paul A. Bonneau
- Observations
- 6
- Pages
- 3
- FEI number
- 1000173162
In short: On January 19, 2016, FDA issued a Form 483 with 6 observations to Laboratoires Merck Sharp & Dohme Chibret in Riom, France (FEI 1000173162) after an inspection that ran Jan 11 – Jan 19, 2016. The investigators were Anita Narula and Paul A. Bonneau. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Au NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Anita Narula
13 documents · 2014–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Oregon.
The firmLaboratoires Merck Sharp & Dohme Chibret history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Laboratoires Merck Sharp & Dohme Chibret?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Laboratoires Merck Sharp & Dohme Chibret?
Anita Narula and Paul A. Bonneau are named on this Form 483, for the inspection of Jan 11 – Jan 19, 2016. Each investigator has a profile showing what they cite most.
When was Laboratoires Merck Sharp & Dohme Chibret inspected by FDA?
The inspection ran Jan 11 – Jan 19, 2016, and the Form 483 is dated January 19, 2016.
How do I get the full Form 483 for Laboratoires Merck Sharp & Dohme Chibret?
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