FDA Inspection 1180736 — Laboratorios Alfa, SRL
The FDA completed an inspection of Laboratorios Alfa, SRL on Sep 16, 2022 in Santo Domingo De Guzman. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 16, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Santo Domingo De Guzman (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |