FDA Inspection 820780 — CSI
The FDA completed an inspection of CSI on March 12, 2013 in Vista, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 12, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Vista, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15392 | 21 CFR 111.10(b)(4) | Jewelry and objects - remove |
| 15396 | 21 CFR 111.10(b)(6) | Hair restraints |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15605 | 21 CFR 111.165(c) | Product received - quarantine |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |