Merck Sharp & Dohme LLC
Form 483 issued January 22, 2025 · Elkton, Virginia
- Inspection
- Jan 8 – Jan 22, 2025
- Investigator
- Brandy N. Lepage
- Observations
- 6
- Pages
- 6
- FEI number
- 1112271
In short: On January 22, 2025, FDA issued a Form 483 with 6 observations to Merck Sharp & Dohme LLC in Elkton, Virginia (FEI 1112271) after an inspection that ran Jan 8 – Jan 22, 2025. The investigator was Brandy N. Lepage. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 6 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 whether or not the batch…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMerck Sharp & Dohme LLC history
All 5 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 6 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Brandy N. Lepage is named on this Form 483, for the inspection of Jan 8 – Jan 22, 2025. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Jan 8 – Jan 22, 2025, and the Form 483 is dated January 22, 2025.
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.