FDA Inspection
IntegraDose Compounding Services LLCIntegraDose Compounding Services LLC – FDA Inspection, Sep 19, 2018
Record Details
This FDA Inspection record concerns IntegraDose Compounding Services LLC, with an inspection on September 19, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Emilie Kahn (Issuing Officer)
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ID · 3669cde9-b927-4da3-ac3a-e7a28f8202c0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1066036
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
6- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of IntegraDose Compounding Services LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2026 | Not classified | Minneapolis District Office | Drug Quality Assurance |
| July 25, 2025 | VAI | Minneapolis District Office | Drug Quality Assurance |
| March 1, 2024 | OAI | Drug Quality Assurance | |
| August 2, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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