FDA Inspection 797008 — Blistex Inc
The FDA completed an inspection of Blistex Inc on August 31, 2012 in Oak Brook, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Oak Brook, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |