Drug factory · FDA FEI 3013162341
Airgas Usa, LLC
11 Ridge Hill Rd, Assonet, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 14, 2019.
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 2019: 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 | 11054-006 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 14, 2019 | 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.
Feb 14, 2019 inspection
- Written procedures not followed 21 CFR 211.122(a)
Written procedures for the examination of packaging and labeling materials are not followed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Registered with FDA for: manufacture.