FDA Inspection 799347 — High Chemical Company, Div Of National Generic Distributors
The FDA completed an inspection of High Chemical Company, Div Of National Generic Distributors on Sep 7, 2012 in Levittown, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Levittown, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |