FDA Inspection 893994 — High Chemical Company, Div Of National Generic Distributors
The FDA completed an inspection of High Chemical Company, Div Of National Generic Distributors on Sep 5, 2014 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 5, 2014
- Fiscal Year
- 2014
- 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 |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1851 | 21 CFR 211.84(e) | Rejecting When Specifications Not Met |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |