FDA Inspection
PreMark Health Science, Inc.PreMark Health Science, Inc. – FDA Inspection, Apr 24, 2014
Record Details
This FDA Inspection record concerns PreMark Health Science, Inc., with an inspection on April 24, 2014, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- Company
- PreMark Health Science, Inc.
- Inspection Date
- April 24, 2014
- Product Type
- Food/cosmetics
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ID · e57d81cd-91da-4f68-ac9a-199160fb5f58
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 877283
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
FDA Citations
12- 21 CFR 110.80(b)(2)Manufacturing conditions
- 21 CFR 111.160(c)(1)Labels - quarantine; samples
- 21 CFR 111.165(c)(1)Product received - quarantine; representative samples
- 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.315(d)Standard reference materials; criteria for selecting
- 21 CFR 111.315(b)Sampling plans; establish, follow
- 21 CFR 111.35(b)(2)Document-equipment date of use, maintain, clean, sanitize
- 21 CFR 111.35(b)(1)(i)Written procedures - instruments, controls; calibrating
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
Showing 10 of 12 citations.
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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 |
| April 14, 2016 | VAI | 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 |
| 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 966496 - 2016-04-14
- FDA Inspection 939325 - 2015-08-25
- FDA Inspection 619354 - 2009-10-14
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