MSD International GmbH (Singapore Branch) — FDA Facility Profile
MSD International GmbH (Singapore Branch) is an FDA-registered facility (FEI 3004611169) located in Singapore, SG. Registered operations: ANALYSIS; MANUFACTURE; STERILIZE. RegDataLab tracks 5 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Sep 26, 2019: No Action Indicated (NAI)
- Inspections on record
- 5 (3 VAI, 2 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 26, 2019 | No Action Indicated (NAI) | No citations listed |
| Mar 16, 2017 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Environmental Monitoring System (21 CFR 211.42(c)(10)(iv)) Equipment to control conditions (21 CFR 211.42(c)(10)(vi)) Written record of investigation incomplete (21 CFR 211.192) |
| Mar 17, 2015 | Voluntary Action Indicated (VAI) | Procedures for sterile drug products (21 CFR 211.113(b)) Lab controls established, including changes (21 CFR 211.160(a)) Sanitation--buildings not clean, free of infestation (21 CFR 211.56(a)) Control procedures to monitor and validate performance (21 CFR 211.110(a)) |
| Mar 5, 2013 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 16, 2010 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- MSD International GmbH (Singapore Branch)
- Location
- Singapore (SG)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; MANUFACTURE; STERILIZE
- Source
- decrs