Drug factory · FDA FEI 2225311
Mada Medical Products, Inc.
625 Washington Avenue, Carlstadt, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 23, 2014.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2011: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Repackages it | Mada Medical Products, Inc. | 11928-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 13, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
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 23, 2014 inspection
- 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. - Not approved or obsolete document retrieval 21 CFR 820.40(a)
Documents that were obsolete were observed at a location where they are being used.
Dec 13, 2011 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions. - Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels are used for drug products are not written and followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the safety, identity, strength, quality or purity of the drug product. - 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. - Examination on receipt, before acceptance 21 CFR 211.82(a)
Each container or grouping of containers of drug product containers is not examined visually upon receipt and before acceptance for appropriate labeling as to contents.
Registered with FDA for: relabel; repack.