FDA Inspection 867839 — Alva-Amco Pharmacal Cos Inc.
The FDA completed an inspection of Alva-Amco Pharmacal Cos Inc. on February 11, 2014 in Niles, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 11, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2198 | 21 CFR 211.186(b)(3) | Component Name and Code |
| 3596 | 21 CFR 211.122(g) | Failure to include one of special control procedures |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |