FDA Inspection 842005 — Allergan Sales, LLC
The FDA completed an inspection of Allergan Sales, LLC on Aug 2, 2013 in Waco, TX. 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
- Aug 2, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Waco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |