Drug factory · FDA FEI 2516287
Greco Gas Inc
Tarentum, Pennsylvania, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Serious problems, FDA action at FDA's last inspection, Apr 5, 2024.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
1 drug inspection on record since 2024: 0 with no problems, 0 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Repackages it | Greco Gas Inc | 10492-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 5, 2024 | Serious problems, FDA action | 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.
Apr 5, 2024 inspection
- Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments, apparatus and gauges is not done at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits are not met. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release. - Identification of each component or in-process material 21 CFR 211.188(b)(3)
Batch production and control records do not include the specific identification of each batch of component and in-process material used for each batch of drug product produced. - 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. - Test results, comparison with standards not included 21 CFR 211.194(a)(6)
Laboratory records do not include a statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the drug product tested. - Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all drug product containers and drug products. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks and inspections of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. - Reports of Analysis (Components) 21 CFR 211.84(d)(2)
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.