Merck Sharp & Dohme LLC
Form 483 issued April 17, 2015 · West Point, Pennsylvania
- Inspection
- Mar 12 – Apr 17, 2015
- Investigators
- Cynthia Jim· Haruhiko Murata· Shuang Tang
- Observations
- 16
- Pages
- 16
- FEI number
- 2510592
In short: On April 17, 2015, FDA issued a Form 483 with 16 observations to Merck Sharp & Dohme LLC in West Point, Pennsylvania (FEI 2510592) after an inspection that ran Mar 12 – Apr 17, 2015. The investigators were Cynthia Jim, Haruhiko Murata, Shuang Tang and Simone E. Pitts. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 10 of 16 observations.
Most cited: 21 CFR 211.165 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing procedures relative to appropriate laboratory testing for…
- 02
The accuracy, sensitivity, specificity, and reproducibility of test methods employed by the firm [are/were] not established…
- 03
Aseptic processing cannot be assured as controls for equipment and facilities are inadequate. There is no…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Cynthia Jim
20 documents · 2012–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 16 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Cynthia Jim, Haruhiko Murata, Shuang Tang and Simone E. Pitts are named on this Form 483, for the inspection of Mar 12 – Apr 17, 2015. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Mar 12 – Apr 17, 2015, and the Form 483 is dated April 17, 2015.
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.