Merck Sharp & Dohme LLC
Form 483 issued July 27, 2021 · West Point, Pennsylvania
- Inspection
- Jul 15 – Jul 27, 2021
- Investigators
- Brentley Collins· Gene D. Arcy· Linda Thai
- Observations
- 4
- Pages
- 4
- FEI number
- 2510592
In short: On July 27, 2021, FDA issued a Form 483 with 4 observations to Merck Sharp & Dohme LLC in West Point, Pennsylvania (FEI 2510592) after an inspection that ran Jul 15 – Jul 27, 2021. The investigators were Brentley Collins, Gene D. Arcy and Linda Thai. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
Facilities & equipment and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A negative pressure exists in a vaccine production area relative to the adjacent corridor that is…
- 02
The roof of Building ® was observed having various areas where water has accumulated, including dirt…
- 03
Your firm manufactures, but is not limited to, prefilled vaccine GLASS syringe products (e.g., Some of…
- 0421 CFR 4.10221 CFR 803.50
Your firm manufactures, but is not limited to, prefilled vaccine GLASS syringe products (e.g., Some of…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, quality system and cAPA. The most-cited regulation is 21 CFR 211.58 (maintenance). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Brentley Collins, Gene D. Arcy and Linda Thai are named on this Form 483, for the inspection of Jul 15 – Jul 27, 2021. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Jul 15 – Jul 27, 2021, and the Form 483 is dated July 27, 2021.
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.