FDA Inspection 712643 — Rotech Healthcare, Inc.
The FDA completed an inspection of Rotech Healthcare, Inc. on Mar 4, 2011 in Windsor, CT. 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Windsor, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |