FDA Inspection
First Boston Pharma LLCFirst Boston Pharma LLC – FDA Inspection, Apr 6, 2009
Record Details
This FDA Inspection record concerns First Boston Pharma LLC, with an inspection on April 6, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- First Boston Pharma LLC
- Inspection Date
- April 6, 2009
- Product Type
- Drugs
View Company Profile
ID · a0206c0a-8222-4ffe-a137-2c34db396f60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 573888
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of First Boston Pharma LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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