FDA Inspection 610893 — Weeks & Leo Co Inc
The FDA completed an inspection of Weeks & Leo Co Inc on September 14, 2009 in Clive, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clive, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3631 | 21 CFR 211.170(b) | Investigation of reserve sample deterioration |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |