FDA Inspection
BioTE MedicalBioTE Medical – FDA Inspection, Nov 4, 2016
Record Details
This FDA Inspection record concerns BioTE Medical, with an inspection on November 4, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · fa232f0b-7deb-4e8d-b4d0-dbf31e1d35a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 991397
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.510Returned dietary supplement - material review, disposition
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Other FDA inspections of BioTE Medical
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2017 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for BioTE Medical
- FDA Inspection 1049209 - 2018-04-23
- FDA Inspection 1028940 - 2017-10-06
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