FDA Inspection 1192889 — RAPHA Health Network International, Inc.
The FDA completed an inspection of RAPHA Health Network International, Inc. on Dec 16, 2022 in Doral, FL. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |