Drug factory · FDA FEI 3003928841
General Air Service & Supply Inc
3031 N Nevada Ave, Colorado Springs, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 18, 2012.
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 2012: 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 | General Air Service & Supply Co. | 21220-119 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 18, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 18, 2012 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. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient. - Identification of Each Lot in Each Shipment 21 CFR 211.80(d)
Each lot in each shipment received was not identified with a distinctive code for each container or grouping of containers for.
Registered with FDA for: manufacture.