FDA Inspection 731542 — Weeks & Leo Co Inc
The FDA completed an inspection of Weeks & Leo Co Inc on June 27, 2011 in Clive, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 27, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clive, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15750 | 21 CFR 111.210(d) | Master manufacturing record - ingredients list |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4329 | 21 CFR 211.122(b) | Rejection of unapproved labeling/packaging materials |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4576 | 21 CFR 211.192 | No written record of investigation |