Mark Cuban Cost Plus Manufacturing and Compounding LLC
Form 483 issued September 6, 2024 · Dallas, Texas
- Inspection
- Aug 26 – Sep 6, 2024
- Investigators
- Camerson E. Moore· Rodney L. Tinzie
- Observations
- 7
- Pages
- 5
- FEI number
- 3024611767
In short: On September 6, 2024, FDA issued a Form 483 with 7 observations to Mark Cuban Cost Plus Manufacturing and Compounding LLC in Dallas, Texas (FEI 3024611767) after an inspection that ran Aug 26 – Sep 6, 2024. The investigators were Camerson E. Moore and Rodney L. Tinzie. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Buildings used in the manufacture, processing, packing, or holding of a diug product do not have…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmMark Cuban Cost Plus Manufacturing and Compounding LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mark Cuban Cost Plus Manufacturing and Compounding LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Mark Cuban Cost Plus Manufacturing and Compounding LLC?
Camerson E. Moore and Rodney L. Tinzie are named on this Form 483, for the inspection of Aug 26 – Sep 6, 2024. Each investigator has a profile showing what they cite most.
When was Mark Cuban Cost Plus Manufacturing and Compounding LLC inspected by FDA?
The inspection ran Aug 26 – Sep 6, 2024, and the Form 483 is dated September 6, 2024.
How do I get the full Form 483 for Mark Cuban Cost Plus Manufacturing and Compounding LLC?
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