FDA Inspection
First Boston Pharma LLCFirst Boston Pharma LLC – FDA Inspection, Nov 15, 2010
Record Details
This FDA Inspection record concerns First Boston Pharma LLC, with an inspection on November 15, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- First Boston Pharma LLC
- Inspection Date
- November 15, 2010
- Product Type
- Drugs
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ID · c54e3d6a-e3b5-4b7f-80bc-0ab3f12c4232
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 699133
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
- 21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 11 citations.
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Other FDA inspections of First Boston Pharma LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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