AIRGAS USA LLC
Overview
AIRGAS USA LLC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering 800 PPM NITROGEN DIOXIDE BALANCE AIR; 80PPM NITROGEN DIOXIDE BALANCE AIR; 80PPM NITROGEN DIOXIDE BALANCE OXYGEN.
Core services & business areas
API / Drug Master Files
AIRGAS USA LLC holds 3 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- 800 PPM NITROGEN DIOXIDE BALANCE AIRActive2011-09-30
- 80PPM NITROGEN DIOXIDE BALANCE OXYGENActive2009-12-04
- 80PPM NITROGEN DIOXIDE BALANCE AIRActive2009-12-04
FDA compliance signals
50 FDA enforcement records linked to this company.
- 4832024-12-16
Calibration/Inspection/Checking not done
- 4832024-12-16
Lab controls established, including changes
- 4832024-09-30
Written records kept in individual logs
- 4832024-09-30
Complete Test Data
- 4832024-09-30
Acceptance criteria for sampling & testing
- 4832024-09-30
Investigations of discrepancies, failures
- 4832024-09-30
Acceptance of drug products
- 4832024-09-30
Defined areas of adequate size for operations
- 4832024-08-15
Records of disposition of rejected material
- 4832024-08-15
Records reviewed annually
- 4832024-07-31
Procedures not in writing, fully followed
- 4832024-02-23
Calibration - at intervals, written program, remedial action
- 4832024-02-23
Strict control not exercised over labeling issued
- 4832024-02-23
Items to cover on annual reviews
- 4832024-02-23
Calibration/Inspection/Checking not done
Is this AIRGAS USA LLC? Get in front of buyers actively sourcing.
We route real sourcing requests from pharma buyers to vetted, verified partners — qualified leads, not just a listing. Tell us what you make and we'll be in touch about becoming a Verified Supplier Partner.
Related companies
Ready to Accelerate Your
Discovery Workflow?
Find, vet, and source drug-manufacturing partners faster — with FDA compliance screening built in. Start free for 7 days.