FDA Inspection 991448 — Nomax, Inc.
The FDA completed an inspection of Nomax, Inc. on October 27, 2016 in Saint Louis, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 27, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 3696 | 21 CFR 820.100(b) | Documentation |