Drug factory · FDA FEI 3019085

Keeler's Medical Supply, Inc.

Yakima, Washington, 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, Jun 26, 2015.

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	Makes it	Keeler's Medical Supply, Inc.	58310-001

Ended	Result	Program	Problems noted
Jun 26, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jun 24, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Label reconciliation discrepancies evaluation/investigation 21 CFR 211.125(c)
Discrepancies found outside preset limits when reconciling the quantities of labeling issued, used and returned, were not evaluated and investigated.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals in accordance with an established written program.
Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not independently checked, dated, and signed by a second person.
Accurate reproduction included 21 CFR 211.188(a)
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of electronic equipment is not performed according to a written program designed to assure proper performance.

Adverse Drug Experience 21 CFR 211.198(a)
Complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse drug experiences which are required to be reported to FDA.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices.