FDA Inspection
Wayne Concept Manufacturing Co., Inc.Wayne Concept Manufacturing Co., Inc. – FDA Inspection, Jan 10, 2013
Record Details
This FDA Inspection record concerns Wayne Concept Manufacturing Co., Inc., with an inspection on January 10, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 10, 2013
- Product Type
- Drugs
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ID · d16873f4-1b88-471f-850a-a56c483d1ad6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814166
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Wayne Concept Manufacturing Co., Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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