FDA Inspection 1237960 — 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 Jun 5, 2024 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |