FDA Inspection 1014292 — Laboratorios Cosmodent SL
The FDA completed an inspection of Laboratorios Cosmodent SL on June 9, 2017 in El Astillero. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 9, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Astillero (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1388 | 21 CFR 211.101(d) | Component addition checked by 2nd person |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1637 | 21 CFR 211.130(e) | Packaging line inspection after use |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |