Drug factory · FDA FEI 2510592
Merck Sharp & Dohme LLC
770 Sumneytown Pike, West Point, PA, United States
No problems found at FDA's last inspection, Dec 12, 2024.
No Action Indicated: inspectors found no objectionable conditions.
7 drug inspections on record since 2010: 1 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, | Makes it | MSP Vaccine Company | 63361-243 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 12, 2024 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 20, 2012 | Problems found, fixed voluntarily | Postmarket Surv. and Epidemiology | — |
| Sep 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 11, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 11, 2011 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Aug 18, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 12, 2014 inspection
- Incoming lots - conformance to written specs- 21 CFR 211.160(b)(1)
Laboratory controls do not include determination of conformance to appropriate written specifications for the acceptance of each lot within each shipment of components and in-process materials used in the manufacture, processing, packing, or holding of drug products. - Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of apparatus not meeting established specifications was observed. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use.
Aug 18, 2010 inspection
- Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.