FDA Inspection
Wayne Concept Manufacturing Co., Inc.Wayne Concept Manufacturing Co., Inc. – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Wayne Concept Manufacturing Co., Inc., with an inspection on March 29, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · f464efed-c5f2-4a9f-80d3-7f7fa3441cfe
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1045956
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
- 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 |
|---|---|---|---|
| November 19, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 10, 2013 | 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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