FDA Inspection 701364 — Obagi Medical Products
The FDA completed an inspection of Obagi Medical Products on Dec 9, 2010 in Milford, CT. 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
- Dec 9, 2010
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Milford, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1768 | 21 CFR 211.137(b) | Storage conditions |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |