FDA Inspection 1110259 — GF Health Products, Inc.
The FDA completed an inspection of GF Health Products, Inc. on November 14, 2019 in Warwick, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 14, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4410 | 21 CFR 211.194(a)(5) | Calculations performed are in the records |