FDA Inspection 838814 — Laboratorios Alfa, SRL
The FDA completed an inspection of Laboratorios Alfa, SRL on Jun 26, 2013 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). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 26, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santo Domingo De Guzman (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 15390 | 21 CFR 111.10(b)(2) | Personnel cleanliness |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15589 | 21 CFR 111.160(c) | Packaging, labels - quarantine |
| 15598 | 21 CFR 111.160(d)(1) | Packaging - identify |
| 15599 | 21 CFR 111.160(d)(1) | Labels - identify |
| 15626 | 21 CFR 111.180(b)(3) | Documentation - packaging |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 16068 | 21 CFR 111.35(b)(1)(iii) | Equipment, utensils; maintaining, cleaning, sanitizing |