Merck Sharp & Dohme LLC
Form 483 issued August 23, 2024 · West Point, Pennsylvania
- Inspection
- Aug 13 – Aug 23, 2024
- Investigators
- Biologics X. Beene· Biologics X. Suse
- Observations
- 3
- Pages
- 7
- FEI number
- 2510592
In short: On August 23, 2024, FDA issued a Form 483 with 3 observations to Merck Sharp & Dohme LLC in West Point, Pennsylvania (FEI 2510592) after an inspection that ran Aug 13 – Aug 23, 2024. The investigators were Biologics X. Beene and Biologics X. Suse. Most observations concern quality system and production.
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination…
This inspection in context
Biologics X. Beene
1 document · 2024
Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMerck Sharp & Dohme LLC history
All 8 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 Sharp & Dohme LLC?
FDA listed 3 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Biologics X. Beene and Biologics X. Suse are named on this Form 483, for the inspection of Aug 13 – Aug 23, 2024. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Aug 13 – Aug 23, 2024, and the Form 483 is dated August 23, 2024.
How do I get the full Form 483 for Merck Sharp & Dohme LLC?
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.