FDA Inspection 1116076 — MANCHESTER VA MEDICAL CENTER
The FDA completed an inspection of MANCHESTER VA MEDICAL CENTER on January 27, 2020 in Manchester, NH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 27, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Manchester, NH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18940 | FDCA 501(a)(2)(A) | Inadequate control, construction adjacent to drug production |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 18955 | FDCA 501(a)(2)(A) | Ceiling tiles, cleanroom |
| 18957 | FDCA 501(a)(2)(A) | Dust-collecting overhangs, surrounding area of ISO 5 |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 18963 | FDCA 501(a)(2)(A) | Inadequate HEPA filter, sterile product area |
| 18970 | FDCA 501(a)(2)(A) | Disinfecting and cleaning agents, ISO 5 area |