FDA Inspection 801001 — Respa Pharmaceuticals Inc.
The FDA completed an inspection of Respa Pharmaceuticals Inc. on Oct 4, 2012 in Addison, IL. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 4, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 17002 | FDCA 501(a) | Drug Field Exam |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |