FDA Inspection 805615 — Wayne Chemical Inc.
The FDA completed an inspection of Wayne Chemical Inc. on Oct 30, 2012 in Fort Wayne, IN. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fort Wayne, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4411 | 21 CFR 211.194(a)(6) | Test results, comparison with standards not included |