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FDA Inspection
•Rocky Mountain Nutrition, LLC•December 12, 2024

Rocky Mountain Nutrition, LLC – FDA Inspection, Dec 12, 2024

Record Details

This FDA Inspection record concerns Rocky Mountain Nutrition, LLC, with an inspection on December 12, 2024, issued by the Dallas District Office, covering foods & cosmetics.

Company
Rocky Mountain Nutrition, LLC
Inspection Date
December 12, 2024
Product Type
Foods & Cosmetics
Office
Dallas District Office
Person
  • Vitaliy N. Guyvan (Issuing Officer)
View Company Profile

ID · 12ca62b6-6bac-4919-bc95-1f3fe6fe18ad

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1256413
FDA center
Foods & Cosmetics
Project area
Food Composition, Standards, Labeling, and Economics
Outcome
Form 483 issued

FDA Citations

10
  1. 21 CFR 111.70(b)Specifications - components
  2. 21 CFR 111.70(d)Specifications - labels, packaging
  3. 21 CFR 111.70(e)Specifications - finished dietary supplement
  4. 21 CFR 111.25Equipment - establish written procedures
  5. 21 CFR 111.103Written procedures - establish; quality control operations
  6. 21 CFR 111.475(b)Records - written procedures holding and distribution; product distribution
  7. 21 CFR 111.255(a)Batch record - every batch
  8. 21 CFR 111.205(a)Master manufacturing record - prepared
  9. 21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
  10. 21 CFR 111.20(h)Physical plant - screening against pests

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Rocky Mountain Nutrition, LLC

1
DateClassificationOfficeProject area
January 13, 2026NAIDallas District OfficeFoodborne Biological Hazards
Other documents for Rocky Mountain Nutrition, LLC
  • FDA Inspection 1298476 - 2026-01-13

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