FDA Inspection
Unit Pack Company IncUnit Pack Company Inc – FDA Inspection, Oct 26, 2009
Record Details
This FDA Inspection record concerns Unit Pack Company Inc, with an inspection on October 26, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Unit Pack Company Inc
- Inspection Date
- October 26, 2009
- Product Type
- Drugs
View Company Profile
ID · 506935d6-24ec-4928-bb42-5bcdaca5be51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 623551
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Unit Pack Company Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 9, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 11, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Unit Pack Company Inc
- FDA Inspection 953347 - 2015-12-09
- FDA Inspection 802704 - 2012-10-11
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