Drug factory · FDA FEI 2000041988
Reliant Holding, Ltd.
31375 Great Western Dr, Windsor, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 21, 2016.
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 2016: 0 with no problems, 1 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 |
|---|---|---|---|
| Jun 21, 2016 | 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.
Jun 21, 2016 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified. - Distinctive ID or code not recorded in batch record 21 CFR 211.105(b)
The batch records do not record the distinctive identification number, code and name of equipment to identify major equipment to show the specific equipment used in the manufacture of a batch of a drug product. - Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures. - 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and of adequate size to facilitate operations for its intended use. - 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. - Components withheld from use pending release 21 CFR 211.84(a)
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
Registered with FDA for: manufacture.