Drug factory · FDA FEI 2242997
I.D.M. Medical Supply Company Inc.
620 Braen Avenue, Wyckoff, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 7, 2017.
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 2017: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | I.D.M. Medical Supply Company Inc. | 49944-001, 49944-010 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 7, 2017 | 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, 2017 inspection
- Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: manufacture.