FDA Inspection 1170966 — ARx LLC
The FDA completed an inspection of ARx LLC on Jun 3, 2022 in Glen Rock, PA. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glen Rock, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |