FDA Inspection 1180969 — Dharma Research, Inc.
The FDA completed an inspection of Dharma Research, Inc. on September 30, 2022 in Miami, FL. 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
- September 30, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4376 | 21 CFR 211.188(b)(4) | Weights and measures of components used |