FDA Inspection 821676 — Weeks & Leo Co Inc
The FDA completed an inspection of Weeks & Leo Co Inc on February 20, 2013 in Clive, IA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 20, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Clive, IA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |