Drug factory · FDA FEI 3007246696
Reliant Holdings, Ltd.
38575H W Cowtown Rd, Maricopa, AZ, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 11, 2015.
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 2014: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Carbon Dioxide | Makes it | Reliant Holdings, Ltd | 65707-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
| Jun 9, 2014 | 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.
Sep 11, 2015 inspection
- Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not established for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs. - Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete manufacturing, control, instructions, sampling, testing, procedures, specifications, special notations, and precautions. - No written record of investigation 21 CFR 211.192
Written records are not made of investigations into unexplained discrepancies. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Adequate lab facilities not available 21 CFR 211.22(b)
Adequate lab facilities for testing and approval or rejection of drug product containers, in-process materials, and drug products are not available to the quality control unit. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Jun 9, 2014 inspection
- Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration, inspection, and checking of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the sampling and testing of components.
Registered with FDA for: manufacture.