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FDA Inspection
•Pelame, LLC•February 28, 2020

Pelame, LLC – FDA Inspection, Feb 28, 2020

Record Details

This FDA Inspection record concerns Pelame, LLC, with an inspection on February 28, 2020, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Pelame, LLC
Inspection Date
February 28, 2020
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · a93bd077-98bd-4d63-acaf-c5b2ee3d8479

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1119406
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

10
  1. 21 CFR 111.83(a)Reserve sample - collect, hold
  2. 21 CFR 111.70(b)(1)Specifications - component identity
  3. 21 CFR 111.70(d)Specifications - labels, packaging
  4. 21 CFR 111.453Written procedures - holding
  5. 21 CFR 111.70(e)Specifications - contamination limits
  6. 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
  7. 21 CFR 111.103Written procedures - quality control operations
  8. 21 CFR 111.553Written procedures - product complaint
  9. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  10. 21 CFR 111.410(d)Manufacturing history

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pelame, LLC

2
DateClassificationOfficeProject area
June 25, 2026VAIDallas District OfficeFood Composition, Standards, Labeling and Econ
June 24, 2021OAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
Other documents for Pelame, LLC
  • FDA Inspection 1288942 - 2026-06-25
  • FDA Inspection 1144633 - 2021-06-24

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