FDA Inspection
Bora Pharmaceuticals Inc.Bora Pharmaceuticals Inc. – FDA Inspection, Dec 19, 2018
Record Details
This FDA Inspection record concerns Bora Pharmaceuticals Inc., with an inspection on December 19, 2018, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · edffcff7-3923-4aa3-8ed2-b74e4c290f60
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075922
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 111.65Quality control - quality, dietary supplement
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Other FDA inspections of Bora Pharmaceuticals Inc.
15| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2024 | Not classified | Minneapolis District Office | |
| November 3, 2022 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 30, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2018 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 21, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Bora Pharmaceuticals Inc.
- FDA Inspection 1242169 - 2024-07-11
- FDA Inspection 1191488 - 2022-11-03
- FDA Inspection 1178557 - 2022-08-30
- FDA Inspection 1075923 - 2018-12-19
- FDA Inspection 1057809 - 2018-06-21
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