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FDA Inspection
•Standard Process, Inc.•July 2, 2012

Standard Process, Inc. – FDA Inspection, Jul 2, 2012

Record Details

This FDA Inspection record concerns Standard Process, Inc., with an inspection on July 2, 2012, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Standard Process, Inc.
Inspection Date
July 2, 2012
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 26f4c735-4df3-447d-b7b8-6b438a251a34

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
789249
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

15
  1. 21 CFR 111.210(h)(2)Master manufacturing record - sampling, tests, examinations
  2. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  3. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  4. 21 CFR 111.70(g)Specifications - finished packaging, labeling
  5. 21 CFR 111.155(d)(1)Components - identify lot produced
  6. 21 CFR 111.65Quality control - quality, dietary supplement
  7. 21 CFR 111.30(c)Equipment - automated - calibrate, inspect
  8. 21 CFR 111.15(c)(1)Cleaning compounds
  9. 21 CFR 111.365(e)Microorganism, decomposition - remove, destroy, prevent
  10. 21 CFR 111.260(j)(1)Batch record - date, each step

Showing 10 of 15 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Standard Process, Inc.

8
DateClassificationOfficeProject area
June 26, 2025NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 9, 2019NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 2, 2017NAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
October 13, 2016NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
February 10, 2015VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 8 other inspections on the company page
Other documents for Standard Process, Inc.
  • FDA Inspection 1274902 - 2025-06-26
  • FDA Inspection 1107935 - 2019-10-09
  • FDA Inspection 1034542 - 2017-11-02
  • FDA Inspection 989866 - 2016-10-13
  • FDA Inspection 913537 - 2015-02-10

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Contact
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Scranton Office:
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