FDA Inspection 725637 — Apria Healthcare Inc
The FDA completed an inspection of Apria Healthcare Inc on June 1, 2011 in Livermore, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 1, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Livermore, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |