FDA Inspection
PreMark Health Science, Inc.PreMark Health Science, Inc. – FDA Inspection, Apr 14, 2016
Record Details
This FDA Inspection record concerns PreMark Health Science, Inc., with an inspection on April 14, 2016, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- PreMark Health Science, Inc.
- Inspection Date
- April 14, 2016
- Product Type
- Food/cosmetics
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ID · a0b3fad5-9e3d-423b-89f2-40e872e2c79f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 966496
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
9- 21 CFR 111.410(b)Label, packaging - discrepancies
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.320(a)Examination, testing; appropriate
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting, QC
- 21 CFR 111.120(b)Quality control operations - specifications; components, packaging, labels
- 21 CFR 111.155(c)(3)Quality control - components, approve, release
- 21 CFR 111.105(a)Quality control - processes, specifications, written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PreMark Health Science, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2022 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| March 28, 2019 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 25, 2015 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| April 24, 2014 | OAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| October 14, 2009 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for PreMark Health Science, Inc.
- FDA Inspection 1177424 - 2022-07-14
- FDA Inspection 1086606 - 2019-03-28
- FDA Inspection 939325 - 2015-08-25
- FDA Inspection 877283 - 2014-04-24
- FDA Inspection 619354 - 2009-10-14
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