FDA Inspection 1178764 — Laboratorios Cosmodent SL
The FDA completed an inspection of Laboratorios Cosmodent SL on September 2, 2022 in El Astillero. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Astillero (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |