FDA Inspection
Davlyn Industries Inc.Davlyn Industries Inc. – FDA Inspection, Jan 11, 2016
Record Details
This FDA Inspection record concerns Davlyn Industries Inc., with an inspection on January 11, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Davlyn Industries Inc.
- Inspection Date
- January 11, 2016
- Product Type
- Drugs
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ID · ee33d304-37c2-4fa3-acfd-d92e0295dac0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958063
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Davlyn Industries Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Davlyn Industries Inc.
- FDA Inspection 793755 - 2012-08-08
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