FDA Inspection 1204028 — Laboratorios Dr. Collado S.A.
The FDA completed an inspection of Laboratorios Dr. Collado S.A. on Apr 21, 2023 in Santo Domingo Norte. 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 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Santo Domingo Norte (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |
| 4576 | 21 CFR 211.192 | No written record of investigation |