Drug factory · FDA FEI 2015545
Airgas Usa, LLC
9010 Clairemont Mesa Blvd, San Diego, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 11, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2022: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Airgas USA, LLC | 11054-130 |
| Nitrogen | Makes it | Airgas USA, LLC | 11054-005, 11054-006 |
| Nitrous Oxide | Makes it | Airgas USA, LLC | 11054-007 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 11, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 11, 2022 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not to facilitate operations for its intended use.
Registered with FDA for: manufacture.