FDA Inspection
Nutrix International LLCNutrix International LLC – FDA Inspection, Apr 25, 2025
Record Details
This FDA Inspection record concerns Nutrix International LLC, with an inspection on April 25, 2025, issued by the Denver District Office, covering human drugs.
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ID · 4a02aa4e-179a-4136-8adc-85becf632627
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1269746
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.103Actual vs. theoretical yields not determined
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.42(b)Adequate space lacking to prevent mix-ups and contamination
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Nutrix International LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2023 | NAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
| April 11, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Nutrix International LLC
- FDA Inspection 1221796 - 2023-10-31
- FDA Inspection 1086064 - 2019-04-11
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