FDA Inspection
Hawknad Manufacturing Industries, Inc.FDA Inspection 718178 - Hawknad Manufacturing Industries, Inc. - April 18, 2011
Record Details
This FDA Inspection record concerns Hawknad Manufacturing Industries, Inc., with an inspection on April 18, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 18, 2011
- Product Type
- Drugs
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ID · 614eff52-ee46-47fb-844d-d88d4fd0a1e1
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 718178
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
12- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
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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 |
| August 15, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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