Drug factory · FDA FEI 3005946698
Superior Oxygen & Medical Supplies, Inc.
545 Penn Ave West, Reading Shopping Center, Reading, PA, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 19, 2010.
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 2010: 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 | Superior Oxygen & Medical Equipment | 24887-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 19, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
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 19, 2010 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Distribution Recall System 21 CFR 211.150(b)
The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. - Identification of each component or in-process material 21 CFR 211.188(b)(3)
Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed. - Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions. - Written calibration / inspection records not kept 21 CFR 211.68(a)
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: manufacture.