FDA Inspection
Hayward Laboratories, Inc.Hayward Laboratories, Inc. – FDA Inspection, Jul 20, 2017
Record Details
This FDA Inspection record concerns Hayward Laboratories, Inc., with an inspection on July 20, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 23e7955b-f989-4eed-a0a6-1b394f67f1d3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1019019
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
9- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
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Other FDA inspections of Hayward Laboratories, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 10, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hayward Laboratories, Inc.
- FDA Inspection 595173 - 2009-06-10
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