FDA Inspection 1080533 — Noxell Corporation
The FDA completed an inspection of Noxell Corporation on February 25, 2019 in Hunt Valley, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 25, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hunt Valley, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |