FDA Inspection 598493 — Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P.
The FDA completed an inspection of Meridian Medical Technologies, LLC A Subsidiary Of Kindeva Drug Delivery, L.P. on Jul 31, 2009 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 31, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |