FDA Inspection 1039527 — Medinatura New Mexico, inc.
The FDA completed an inspection of Medinatura New Mexico, inc. on February 2, 2018 in Albuquerque, NM. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albuquerque, NM (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |