Merck Sharp & Dohme LLC
Form 483 issued April 30, 2019 · West Point, Pennsylvania
- Inspection
- Apr 22 – Apr 30, 2019
- Investigators
- Anastasia I. Offordile· Kelly N. Kerr
- Observations
- 1
- Pages
- 1
- FEI number
- 2510592
In short: On April 30, 2019, FDA issued a Form 483 with 1 observation to Merck Sharp & Dohme LLC in West Point, Pennsylvania (FEI 2510592) after an inspection that ran Apr 22 – Apr 30, 2019. The investigators were Anastasia I. Offordile and Kelly N. Kerr. Most observations concern gLP; the most-cited regulation is 21 CFR 58.130 (conduct of a nonclinical laboratory study).
At a glance
1 of 1 observations on this 483 concern glp.
Most cited: 21 CFR 58.130 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Not all nonclinical laboratory studies were conducted in…
This inspection in context
Anastasia I. Offordile
1 document · 2019
Cites 58.130 (conduct of a nonclinical laboratory study) 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 58.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 1 observation on this Form 483, mostly about gLP. The most-cited regulation is 21 CFR 58.130 (conduct of a nonclinical laboratory study). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Anastasia I. Offordile and Kelly N. Kerr are named on this Form 483, for the inspection of Apr 22 – Apr 30, 2019. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Apr 22 – Apr 30, 2019, and the Form 483 is dated April 30, 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.