FDA Inspection
Biovation LabsBiovation Labs – FDA Inspection, Mar 2, 2015
Record Details
This FDA Inspection record concerns Biovation Labs, with an inspection on March 2, 2015, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- Biovation Labs
- Inspection Date
- March 2, 2015
- Product Type
- Food/cosmetics
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ID · 0a6c21f0-9fd4-4fdb-ace7-d4f20b530f82
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 914902
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
13- 21 CFR 111.12(c)Personnel - education, training, experience
- 21 CFR 111.210(h)(3)(ii)(B)Components; add, verify
- 21 CFR 111.210(h)(5)Corrective action plans
- 21 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
- 21 CFR 111.75(h)Tests, examinations - scientifically valid
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.255(c)Batch record - each step
- 21 CFR 111.30(c)Equipment - automated - calibrate, inspect
- 21 CFR 111.260(j)(2)(iv)Batch record - initials; verifying component
Showing 10 of 13 citations.
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Other FDA inspections of Biovation Labs
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2023 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 9, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 10, 2017 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| May 6, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 17, 2015 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Biovation Labs
- FDA Inspection 1225008 - 2023-12-01
- FDA Inspection 1055447 - 2018-05-09
- FDA Inspection 1007025 - 2017-04-10
- FDA Inspection 981036 - 2016-05-06
- FDA Inspection 919461 - 2015-03-17
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