FDA Inspection 919932 — Johnson & Johnson Consumer, Inc
The FDA completed an inspection of Johnson & Johnson Consumer, Inc on Mar 27, 2015 in Lancaster, 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 27, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lancaster, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |