Merck Sharp & Dohme LLC
Form 483 issued April 16, 2021 · Durham, North Carolina
- Inspection
- Apr 7 – Apr 16, 2021
- Investigator
- Laurel A. Beer
- Observations
- 5
- Pages
- 6
- FEI number
- 3006525584
In short: On April 16, 2021, FDA issued a Form 483 with 5 observations to Merck Sharp & Dohme LLC in Durham, North Carolina (FEI 3006525584) after an inspection that ran Apr 7 – Apr 16, 2021. The investigator was Laurel A. Beer. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There wasa failure to handle and store closures at all times in a…
- 02
Buildings used in the manufacturing of a drug product are not maintained in a…
- 03
The quality control unit lacks authority to fully investigate…
- 04
Batch production and control records do not include complete information relating to the production and…
This inspection in context
Laurel A. Beer
14 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmMerck Sharp & Dohme LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.80(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Laurel A. Beer is named on this Form 483, for the inspection of Apr 7 – Apr 16, 2021. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Apr 7 – Apr 16, 2021, and the Form 483 is dated April 16, 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.