FDA Inspection 823917 — I. Shay Cosmetics Inc
The FDA completed an inspection of I. Shay Cosmetics Inc on March 14, 2013 in Harbor City, CA. 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: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 14, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Harbor City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |