Merck Sharp & Dohme LLC
Form 483 issued August 24, 2012 · Elkton, Virginia
- Inspection
- Aug 13 – Aug 24, 2012
- Investigators
- Brooke K. Higgins· Nebil A. Oumer
- Observations
- 2
- Pages
- 3
- FEI number
- 1112271
In short: On August 24, 2012, FDA issued a Form 483 with 2 observations to Merck Sharp & Dohme LLC in Elkton, Virginia (FEI 1112271) after an inspection that ran Aug 13 – Aug 24, 2012. The investigators were Brooke K. Higgins and Nebil A. Oumer. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.42(c)(10)(iii) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
This inspection in context
Brooke K. Higgins
5 documents · 2011–2014
Cites 211.42(c)(10) (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Brooke K. Higgins and Nebil A. Oumer are named on this Form 483, for the inspection of Aug 13 – Aug 24, 2012. 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 24, 2012, and the Form 483 is dated August 24, 2012.
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.