FDA Inspection
Bunce Rental, Inc. dba American Medical Rental & SupplyBunce Rental, Inc. dba American Medical Rental & Supply – FDA Inspection, Jan 25, 2011
Record Details
This FDA Inspection record concerns Bunce Rental, Inc. dba American Medical Rental & Supply, with an inspection on January 25, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 25, 2011
- Product Type
- Drugs
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ID · 22d1c7b2-13bb-4aaf-b2b2-d779d896c86b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 707174
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.137(b)Storage conditions
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.142(a)Quarantine - actual practice
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.125(f)Procedures Written and Followed
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Other FDA inspections of Bunce Rental, Inc. dba American Medical Rental & Supply
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 24, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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