FDA Inspection 661205 — Wayne Concept Manufacturing Co., Inc.
The FDA completed an inspection of Wayne Concept Manufacturing Co., 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). 9 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4369 | 21 CFR 211.188(b)(11) | Identification of persons involved, each significant step |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |