FDA Inspection 767484 — 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 Feb 13, 2012 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2012
- Fiscal Year
- 2012
- 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 |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |