FDA Inspection 941229 — Cosmedx Science Inc.
The FDA completed an inspection of Cosmedx Science Inc. on August 26, 2015 in Corona, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4342 | 21 CFR 211.142(b) | Storage under appropriate conditions |