FDA Inspection
Blispak, Inc.Blispak, Inc. – FDA Inspection, Apr 12, 2012
Record Details
This FDA Inspection record concerns Blispak, Inc., with an inspection on April 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Blispak, Inc.
- Inspection Date
- April 12, 2012
- Product Type
- Drugs
View Company Profile
ID · e7b59499-5e68-435b-825b-e308ba27697e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 777587
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.130(e)Packaging line inspection before use
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.134(c)Examinations documented
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Other FDA inspections of Blispak, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 9, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Blispak, Inc.
- FDA Inspection 986814 - 2016-09-19
- FDA Inspection 899132 - 2014-10-09
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