Drug factory · FDA FEI 1317301
Maine Oxy NY, Inc.
101 Comet Ave, Buffalo, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 5, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Maine Oxy-Acetylene Supply Company | 51887-720 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 5, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Aug 5, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 5, 2024 inspection
- Lot or control number assigned 21 CFR 211.130(c)
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. - Lot or control number assigned 21 CFR 211.130(c)
The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - 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. - 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.