Drug factory · FDA FEI 1015040

Nexair, LLC

150 Stockton St, Jacksonville, FL, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 11, 2024.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

3 drug inspections on record since 2010: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Air	Makes it	NexAir, LLC, Praxair Distribution Southeast LLC	12213-700, 49972-006
Carbon Dioxide	Makes it	NexAir, LLC, Praxair Distribution Southeast LLC	12213-900, 49972-003
Nitrogen	Makes it	NexAir, LLC, Praxair Distribution Southeast LLC	12213-498, 49972-002
Nitrous Oxide	Makes it	NexAir, LLC, Praxair Distribution Southeast LLC	12213-593, 49972-004
Oxygen	Makes it	NexAir, LLC, Praxair Distribution Southeast LLC	12213-720, 49972-001

Ended	Result	Program	Problems noted
Jul 11, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	2
Oct 16, 2012	No problems found	Drug Quality Assurance	—
May 3, 2010	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture.