Drug factory · FDA FEI 3001451808
Quality Air Products Inc
2829 FORT WORTH AVE, Dallas, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 16, 2010.
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 2010: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrous Oxide | Makes it | Quality Air Products Inc | 63978-201 |
| Oxygen | Makes it | Quality Air Products Inc | 63978-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 16, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 16, 2010 inspection
- Identification of containers, lines, equipment 21 CFR 211.105(a)
All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents. - Written warehousing procedures established/followed 21 CFR 211.142
Procedures describing the warehousing of drug products are not established. - Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of gauges is not done at suitable intervals in accordance with an established written program. - Description of containers, labels, et. al. 21 CFR 211.186(b)(8)
Master production and control records lack a specimen or copy of each label and all other labeling. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records are not prepared for each batch of drug product produced. - Accurate reproduction included 21 CFR 211.188(a)
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed. - Actual yield, % of theoretical yield 21 CFR 211.188(b)(7)
The batch production and control records do not include a statement of the actual yield at appropriate stages of processing for each batch of drug product produced. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance. - Handling and Storage to Prevent Contamination 21 CFR 211.80(b)
There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.
Registered with FDA for: manufacture.