Merck Sharp & Dohme LLC
Form 483 issued September 20, 2019 · West Point, Pennsylvania
- Inspection
- Sep 9 – Sep 20, 2019
- Investigators
- Chris J. Adams· Eileen A. Liu· Linda Thai
- Observations
- 15
- Pages
- 11
- FEI number
- 2510592
In short: On September 20, 2019, FDA issued a Form 483 with 15 observations to Merck Sharp & Dohme LLC in West Point, Pennsylvania (FEI 2510592) after an inspection that ran Sep 9 – Sep 20, 2019. The investigators were Chris J. Adams, Eileen A. Liu, Linda Thai and Prabhu P. Raju. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
5 of 6 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (4×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Deficiencies were observed in the handling of deviations in the production of…
- 04
Written records of investigations for the following Product Quality Complaints (PQCs) and Adverse Event Quality Investigation…
This inspection in context
Chris J. Adams
1 document · 2019
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 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 15 observations on this Form 483, mostly about quality system. 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?
Chris J. Adams, Eileen A. Liu, Linda Thai and Prabhu P. Raju are named on this Form 483, for the inspection of Sep 9 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Sep 9 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Merck Sharp & Dohme LLC?
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