FDA Inspection
Hawknad Manufacturing Industries, Inc.FDA Inspection 980679 - Hawknad Manufacturing Industries, Inc. - April 28, 2016
Record Details
This FDA Inspection record concerns Hawknad Manufacturing Industries, Inc., with an inspection on April 28, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 28, 2016
- Product Type
- Drugs
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ID · 1950cd1f-f93c-4b7e-947d-5d17b1104f4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 980679
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.42(c)(1)Incoming material area
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Hawknad Manufacturing Industries, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| August 15, 2012 | 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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