Drug factory · FDA FEI 3003276259
Med Resources, Inc.
14805 North Outer 40 Rd Lower Level, Chesterfield, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 17, 2011.
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 2010: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oxygen | Makes it | Med Resources, Inc. | 66314-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 17, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 12 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 1, 2010 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not. - Actual vs. theoretical yields not determined 21 CFR 211.103
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing and holding of the drug product. - Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. - Written distribution procedure 21 CFR 211.150
Written distribution procedures are not established. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity, strength, quality, and purity of drug products. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the education and training required to perform their assigned functions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. - Cleaning/maintenance records not kept 21 CFR 211.67(c)
Records are not kept for the maintenance, cleaning, sanitizing, and inspection of equipment. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance. - Procedures To Be in Writing 21 CFR 211.80(a)
Written procedures are lacking which describe in sufficient detail the receipt, approval, and rejection of drug product containers.
Registered with FDA for: manufacture.