Drug factory · FDA FEI 1312846
Airgas Usa, LLC
121 Boxwood Ln, Syracuse, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 18, 2018.
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 2018: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Airgas USA, LLC | 11054-005, 11054-006 |
| Oxygen | Makes it | Airgas USA, LLC | 11054-009, 11054-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jan 18, 2018 inspection
- Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include specimen and copy of labeling. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.
Registered with FDA for: manufacture.