FDA Inspection 672404 — Austin Respiratory
The FDA completed an inspection of Austin Respiratory on Jul 14, 2010 in Clearwater, FL. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 14, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Clearwater, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 2023 | 21 CFR 211.188(b)(11) | Identification of Persons Performing Significant Steps |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |