FDA Inspection 661196 — Wayne Chemical Inc.
The FDA completed an inspection of Wayne Chemical Inc. on Apr 30, 2010 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 30, 2010
- Fiscal Year
- 2010
- 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 |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |