FDA Inspection 1034137 — I. Shay Cosmetics Inc
The FDA completed an inspection of I. Shay Cosmetics Inc on December 7, 2017 in Harbor City, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 7, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Harbor City, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2020 | 21 CFR 211.188(b)(8) | Labeling Control Records and Label Copies |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 21296 | 21 CFR 211.186(a) | Master production and control records, batch uniformity |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |