FDA Inspection 974531 — R & R Lotion Inc
The FDA completed an inspection of R & R Lotion Inc on Jun 6, 2016 in Scottsdale, AZ. 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
- Jun 6, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4368 | 21 CFR 211.188(b)(12) | Investigations made into any unexplained discrepancy |