FDA Inspection
B F Ascher & Co IncB F Ascher & Co Inc – FDA Inspection, Jul 15, 2015
Record Details
This FDA Inspection record concerns B F Ascher & Co Inc, with an inspection on July 15, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- B F Ascher & Co Inc
- Inspection Date
- July 15, 2015
- Product Type
- Drugs
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ID · c17094e6-6e90-4dd4-b0d5-b9fae1a9f2af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 935268
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.166(a)(3)Valid stability test methods
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Other FDA inspections of B F Ascher & Co Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 22, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 29, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 30, 2009 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for B F Ascher & Co Inc
- FDA Inspection 730793 - 2011-06-22
- FDA Inspection 660782 - 2010-04-29
- FDA Inspection 579086 - 2009-04-30
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