FDA Inspection 1069221 — Redicare LLC
The FDA completed an inspection of Redicare LLC on Oct 19, 2018 in Congers, NY. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Congers, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1777 | 21 CFR 211.150(b) | Distribution Recall System |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 2001 | 21 CFR 211.184(b) | Component Test Records |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |