FDA Inspection 646312 — Lannett Company, Inc.
The FDA completed an inspection of Lannett Company, Inc. on February 9, 2010 in Philadelphia, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 3641 | 21 CFR 211.204 | Record information inclusions |
| 4417 | 21 CFR 211.204 | Associated batches implicated, investigated |