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FDA Inspection
•BodyBio Inc.•April 26, 2024

FDA Inspection 1237109 - BodyBio Inc. - April 26, 2024

Record Details

This FDA Inspection record concerns BodyBio Inc., with an inspection on April 26, 2024, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
BodyBio Inc.
Inspection Date
April 26, 2024
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
People
  • Brandon M. Kurjanowicz (Issuing Officer)
  • Gary C. Pecic (FDA Associated Person)
  • Jessica M. Monteiro (Company Rep)
  • Ramanda C. Gregory (Issuing Officer)
View Company Profile

ID · 257c5788-bd28-4406-880c-6e6d4c341553

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1237109
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling and Econ

FDA Citations

13
  1. 21 CFR 111.560(a)(2)Product complaint - quality control investigate
  2. 21 CFR 111.415(a)Clean, sanitize - filling, packaging equipment
  3. 21 CFR 111.70(b)(1)Specifications - component identity
  4. 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
  5. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  6. 21 CFR 111.75(a)(2)(ii)(C)Documentation - qualify supplier
  7. 21 CFR 111.205(a)Master manufacturing record - each batch
  8. 21 CFR 111.320(a)Examination, testing; appropriate
  9. 21 CFR 111.260(f)Batch record - yield
  10. 21 CFR 111.260(c)Batch record - date, time; maintenance

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of BodyBio Inc.

5
DateClassificationOfficeProject area
October 30, 2025NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
April 18, 2019VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
November 29, 2016VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
October 30, 2013VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
September 4, 2009NAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for BodyBio Inc.
  • FDA Inspection 1292888 - 2025-10-30
  • FDA Inspection 1086637 - 2019-04-18
  • FDA Inspection 996675 - 2016-11-29
  • FDA Inspection 853026 - 2013-10-30
  • FDA Inspection 610352 - 2009-09-04

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