FDA Inspection
Hawknad Manufacturing Industries, Inc.FDA Inspection 793901 - Hawknad Manufacturing Industries, Inc. - August 15, 2012
Record Details
This FDA Inspection record concerns Hawknad Manufacturing Industries, Inc., with an inspection on August 15, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 15, 2012
- Product Type
- Drugs
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ID · 2de1be48-9fe0-41e1-85f0-d2eafd7fc58a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793901
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Hawknad Manufacturing Industries, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 23, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 18, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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