FDA Inspection 611879 — HNC Products Inc.
The FDA completed an inspection of HNC Products Inc. on September 11, 2009 in Clinton, IL. 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
- September 11, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clinton, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |