FDA Inspection 1208533 — G&C Pharmaceuticals, Inc.
The FDA completed an inspection of G&C Pharmaceuticals, Inc. on Jun 21, 2023 in Moca, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 21, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Moca, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |