FDA Inspection
Micra Biotechnologies, Inc.Micra Biotechnologies, Inc. – FDA Inspection, Mar 10, 2015
Record Details
This FDA Inspection record concerns Micra Biotechnologies, Inc., with an inspection on March 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Micra Biotechnologies, Inc.
- Inspection Date
- March 10, 2015
- Product Type
- Drugs
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ID · dd98227c-f6b1-4b10-926e-c0797ca7cbf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916518
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.160(a)Deviations from laboratory control requirements
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.194(a)(2)Reference and method not stated
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Micra Biotechnologies, Inc.
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| August 2, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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| January 30, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 23, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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