FDA Inspection 864911 — Alopecil Corporation, S.R.L.
The FDA completed an inspection of Alopecil Corporation, S.R.L. on January 15, 2014 in Santo Domingo. 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) (VAI)
- End Date
- January 15, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Santo Domingo (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15447 | 21 CFR 111.15(c)(3) | Cleaning compounds and toxic materials - holding |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15553 | 21 CFR 111.260(j)(2)(i) | Batch record - initials; weighing |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15948 | 21 CFR 111.110 | Quality control operations - laboratory operations |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |
| 904 | 21 CFR 123.6(b) | No HACCP plan |