Merck Sharp & Dohme LLC
Form 483 issued March 4, 2020 · Elkton, Virginia
- Inspection
- Feb 25 – Mar 4, 2020
- Investigators
- Burnell M. Henry· Susan M. Jackson
- Observations
- 4
- Pages
- 4
- FEI number
- 1112271
In short: On March 4, 2020, FDA issued a Form 483 with 4 observations to Merck Sharp & Dohme LLC in Elkton, Virginia (FEI 1112271) after an inspection that ran Feb 25 – Mar 4, 2020. The investigators were Burnell M. Henry and Susan M. Jackson. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Corrective and preventive actions assigned to quality notifications for foreign material and particles in the spray…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Failure to make a record of the conclusions and follow-up of a failure of a lot…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
This inspection in context
Burnell M. Henry
22 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in North Carolina.
The firmMerck Sharp & Dohme LLC history
All 5 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 4 observations on this Form 483, mostly about quality system and laboratory controls. 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?
Burnell M. Henry and Susan M. Jackson are named on this Form 483, for the inspection of Feb 25 – Mar 4, 2020. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Feb 25 – Mar 4, 2020, and the Form 483 is dated March 4, 2020.
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.