FDA Inspection 1005459 — Laboratorios Alfa, SRL
The FDA completed an inspection of Laboratorios Alfa, SRL on Dec 16, 2016 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). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santo Domingo De Guzman (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 15436 | 21 CFR 111.15(a) | Grounds - condition |
| 15452 | 21 CFR 111.15(f)(5) | Plumbing - backflow, cross connection |
| 15458 | 21 CFR 111.20(d)(1)(i) | Floors, walls, ceilings |
| 15462 | 21 CFR 111.20(d)(1)(iv) | Physical plant - temperature, humidity controls |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |