Drug factory · FDA FEI 3006400017

Medicor Homecare, Inc.

Tampa, Florida, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Problems found, fixed voluntarily at FDA's last inspection, Sep 23, 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	Medicor Homecare, Inc.	36006-001

Ended	Result	Program	Problems noted
Sep 23, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	5

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch.
Identification of persons involved, each significant step 21 CFR 211.188(b)(11)
Batch production and control records do not include the identification of the persons checking each significant step in the operation, for each batch of drug product produced.
Approve or reject components, products 21 CFR 211.22(a)
The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, labeling, and drug products.
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.