Drug factory · FDA FEI 3030693939
Rocky Mountain Medical Equipment LLC
7000 Broadway Ste 412, Denver, CO, United States
No problems found at FDA's last inspection, Mar 5, 2012.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2011: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Rocky Mountain Medical Equipment LLC | 84233-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 5, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 19, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
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 19, 2011 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. - 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. - Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person. - Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, and packing. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - 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. - 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.
Registered with FDA for: manufacture.