FDA Inspection 1015459 — Cosmetic Solutions LLC
The FDA completed an inspection of Cosmetic Solutions LLC on Apr 14, 2017 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4360 | 21 CFR 211.170(b) | Reserve drug product sample quantity - all tests |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |