FDA Inspection 614855 — American Copak Corporation
The FDA completed an inspection of American Copak Corporation on September 25, 2009 in Chatsworth, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 25, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chatsworth, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12732 | 21 CFR 120.10(a) | Corrective action - predetermined plan |
| 12733 | 21 CFR 120.11(a)(1)(iv)(C) | Calibration, testing - record review timeliness |
| 12744 | 21 CFR 120.8(b)(4) | HACCP plan - monitoring procedures - none listed |
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12749 | 21 CFR 120.8(b)(6) | HACCP plan - verify procedures / frequency - none listed |
| 15439 | 21 CFR 111.15(a)(3) | Grounds - drainage areas |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9954 | 21 CFR 120.11(a)(1)(iv) | Verification - CCP, CA record review |