FDA Inspection
Cosmax Bio, Inc.Cosmax Bio, Inc. – FDA Inspection, Nov 10, 2017
Record Details
This FDA Inspection record concerns Cosmax Bio, Inc., with an inspection on November 10, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9b2a9a81-8829-476c-986d-75b68852ae95
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1032092
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.194(a)(7)Identification of Person Performing the Testing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Cosmax Bio, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 30, 2024 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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