FDA Inspection 640926 — Apria Healthcare Inc.
The FDA completed an inspection of Apria Healthcare Inc. on January 20, 2010 in North Franklin, CT. 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
- January 20, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- North Franklin, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |