Drug factory · FDA FEI 3010161130
Dusara Corporation dba UniversalMed Supply
1329 W Walnut Hill Ste 100, Irving, TX, United States
No problems found at FDA's last inspection, Dec 22, 2014.
No Action Indicated: inspectors found no objectionable conditions.
1 drug inspection on record since 2014: 1 with no problems, 0 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Dusara Corporation dba UniversalMed Supply | 73093-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Dec 22, 2014 | No problems found | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 22, 2014 inspection
- Written procedures describing in detail 21 CFR 211.122(a)
There is a lack of written procedures describing in sufficient detail the receipt, identification, storage, handling, and examination of labeling and packaging materials. - 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. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include assignment of responsibility, maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and parameters relevant to the operation.
Registered with FDA for: manufacture.