Merck Sharp & Dohme LLC
Form 483 issued June 28, 2019 · Elkton, Virginia
- Inspection
- Jun 24 – Jun 28, 2019
- Investigator
- David A. Oluwo
- Observations
- 2
- Pages
- 4
- FEI number
- 1112271
In short: On June 28, 2019, FDA issued a Form 483 with 2 observations to Merck Sharp & Dohme LLC in Elkton, Virginia (FEI 1112271) after an inspection that ran Jun 24 – Jun 28, 2019. The investigator was David A. Oluwo. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.42(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The operations relating to the manufacture, processing and packing of penicillin are not performed in facilities…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
David A. Oluwo
27 documents · 2017–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Maryland.
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 211.42(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
David A. Oluwo is named on this Form 483, for the inspection of Jun 24 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Jun 24 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
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.