FDA Inspection
IntegraDose Compounding Services LLCIntegraDose Compounding Services LLC – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns IntegraDose Compounding Services LLC, with an inspection on August 12, 2026, issued by the Minneapolis District Office, covering human drugs.
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ID · 8b5301b4-e3ce-4899-b6e0-51d85e70182f
Inspection Facts
- Inspection number
- 1330602
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of IntegraDose Compounding Services LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| September 19, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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