FDA Inspection 958350 — Centro Naturista
The FDA completed an inspection of Centro Naturista on February 4, 2016 in Dallas, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15880 | 21 CFR 111.75(f)(2) | Label - visual examination, review supplier's documentation |
| 15881 | 21 CFR 111.75(g) | Packaging, labeling - visual examination |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |