FDA Inspection 561555 — R & R Lotion Inc
The FDA completed an inspection of R & R Lotion Inc on Feb 4, 2009 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 4, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |