Merck Sharp & Dohme LLC
Form 483 issued October 26, 2018 · Elkton, Virginia
- Inspection
- Oct 18 – Oct 26, 2018
- Investigator
- Justin A. Boyd
- Observations
- 6
- Pages
- 7
- FEI number
- 1112271
In short: On October 26, 2018, FDA issued a Form 483 with 6 observations to Merck Sharp & Dohme LLC in Elkton, Virginia (FEI 1112271) after an inspection that ran Oct 18 – Oct 26, 2018. The investigator was Justin A. Boyd. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 4 of 6 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Discrepancies are not thoroughly investigated. 1. On May 07, Sl 4501 "Antibiotic Containment Monitoring/Detection at Elkton…
- 02
Measures to prevent cross-contamination via personnel movement from one dedicated area to other areas have…
- 03
Issuance and use of…
- 04
Procedures to review and control electronic…
This inspection in context
Justin A. Boyd
61 documents · 2010–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Sharp & Dohme LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Merck Sharp & Dohme LLC?
Justin A. Boyd is named on this Form 483, for the inspection of Oct 18 – Oct 26, 2018. Each investigator has a profile showing what they cite most.
When was Merck Sharp & Dohme LLC inspected by FDA?
The inspection ran Oct 18 – Oct 26, 2018, and the Form 483 is dated October 26, 2018.
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.