Drug factory · FDA FEI 3003722695
General Distributing Company
800 Florence, Helena, MT, United States
Problems found, fixed voluntarily at FDA's last inspection, May 6, 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 | General Distributing Co. | 10451-003 |
| Oxygen | Makes it | General Distributing Co. | 10451-001, 10451-004 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 6, 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.
May 6, 2019 inspection
- 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. - Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store components and drug product containers at all times in a manner to prevent contamination.
Registered with FDA for: manufacture; repack.