Drug factory · FDA FEI 1022618
Airgas Usa, LLC
4551 N Access Rd, Chattanooga, TN, United States
No problems found at FDA's last inspection, Mar 30, 2011.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2010: 1 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 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, 11054-110 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 30, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 19, 2010 | Serious problems, FDA action | Drug Quality Assurance | 7 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 19, 2010 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced. - Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons performing and checking each significant step in the operation, for each batch of drug product produced. - Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the sampling, testing, and approval of components, drug product containers, and closures. - Exam for Filth, Insects, Extraneous Adulterants 21 CFR 211.84(d)(5)
Each lot of drug product containers that is liable to contamination with filth, insect infestation or other extraneous adulterants is not examined against established specifications for such contamination.
Registered with FDA for: manufacture.