FDA Inspection 976844 — Alopecil Corporation, S.R.L.
The FDA completed an inspection of Alopecil Corporation, S.R.L. on June 8, 2016 in Santo Domingo. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 8, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santo Domingo (Dominican Republic (the))
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15741 | 21 CFR 111.210(h)(3)(i) | Components, verify weight, measure |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15940 | 21 CFR 111.105(h) | Quality control - production, process control |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |