FDA Inspection
Hawknad Manufacturing Industries, Inc.FDA Inspection 921846 - Hawknad Manufacturing Industries, Inc. - April 23, 2015
Record Details
This FDA Inspection record concerns Hawknad Manufacturing Industries, Inc., with an inspection on April 23, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 23, 2015
- Product Type
- Drugs
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ID · ac681747-78e3-4968-9314-406b9e98ba16
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921846
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(b)Tentative expiration date
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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 |
| 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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