FDA Inspection
Mark Cuban Cost Plus Manufacturing and Compounding LLCMark Cuban Cost Plus Manufacturing and Compounding LLC – FDA Inspection, Sep 30, 2026
Record Details
This FDA Inspection record concerns Mark Cuban Cost Plus Manufacturing and Compounding LLC, with an inspection on September 30, 2026, issued by the Dallas District Office, covering human drugs.
- Inspection Date
- September 30, 2026
- Product Type
- Human Drugs
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ID · 743c4d66-5b9e-49b6-b51f-a682d8b9f276
Inspection Facts
- Inspection number
- 1338624
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Test devices not meeting specifications
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
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Other FDA inspections of Mark Cuban Cost Plus Manufacturing and Compounding LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2024 | VAI | Dallas District Office | Drug Quality Assurance |
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