FDA Inspection
Canberra CorporationCanberra Corporation – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns Canberra Corporation, with an inspection on February 21, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Canberra Corporation
- Inspection Date
- February 21, 2013
- Product Type
- Drugs
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ID · 5a37867f-6e32-4061-a3c4-baee1061c23b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 816541
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
22- 21 CFR 211.122(d)Label storage access limited to authorized personnel
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(a)Following/documenting laboratory controls
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Other FDA inspections of Canberra Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 26, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 14, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 11, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 3, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Canberra Corporation
- FDA Inspection 871450 - 2014-03-26
- FDA Inspection 683537 - 2010-09-14
- FDA Inspection 674022 - 2010-08-11
- FDA Inspection 648844 - 2010-03-03
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