FDA Inspection
Neutripure CorporationFDA Inspection 1287422 - Neutripure Corporation - October 17, 2025
Record Details
This FDA Inspection record concerns Neutripure Corporation, with an inspection on October 17, 2025, issued by the Minneapolis District Office, covering human drugs.
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ID · 098808a2-aa95-4fd2-af9e-b86636bdd2a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1287422
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.100(a)Absence of Written Procedures
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