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FDA Inspection
•Standard Process, Inc.•September 10, 2013

Standard Process, Inc. – FDA Inspection, Sep 10, 2013

Record Details

This FDA Inspection record concerns Standard Process, Inc., with an inspection on September 10, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Standard Process, Inc.
Inspection Date
September 10, 2013
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · adaa0eaf-763a-401b-a686-395e88c2a67d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
848709
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

9
  1. 21 CFR 111.355Manufacturing operations - design
  2. 21 CFR 111.73Specifications met - received product identified
  3. 21 CFR 111.75(h)Tests, examinations - scientifically valid
  4. 21 CFR 111.70(e)Specifications - contamination limits
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.75(c)(3)Specifications met identity,purity, strength, comp,; basis
  7. 21 CFR 111.27(a)Equipment - design - suitable
  8. 21 CFR 111.255(b)Batch record - complete
  9. 21 CFR 111.210(f)Master manufacturing record theoretical and expected yield

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
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
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