FDA Inspection
Wayne Chemical Inc.Wayne Chemical Inc. – FDA Inspection, Oct 30, 2012
Record Details
This FDA Inspection record concerns Wayne Chemical Inc., with an inspection on October 30, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wayne Chemical Inc.
- Inspection Date
- October 30, 2012
- Product Type
- Drugs
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ID · a9a91163-b240-48e9-abab-3369b77fd877
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805615
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.194(a)(6)Test results, comparison with standards not included
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Wayne Chemical Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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