Drug factory · FDA FEI 3007142805
DJB Gas Services, Inc
1177 Swaner Rd, Salt Lake City, UT, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2018.
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 2018: 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 | DJB Gas Services, Inc | 43621-007 |
| Nitrogen | Makes it | DJB Gas Services, Inc | 43621-002 |
| Nitrous Oxide | Makes it | DJB Gas Services, Inc | 43621-003 |
| Oxygen | Makes it | DJB Gas Services, Inc | 43621-001, 43621-004 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 7, 2018 inspection
- Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include specimen of labeling. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Registered with FDA for: manufacture.