Drug factory · FDA FEI 3005408396

Calmar dba A&R Medical Supply

5010 Lomas Blvd NE, Albuquerque, NM, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2012.

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	Calmar dba A&R Medical Supply	16175-0001

Ended	Result	Program	Problems noted
Sep 12, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	5
Nov 4, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	3

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

Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
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.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt of drug product containers.
Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

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 prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
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, closures, in process materials, packaging material, labeling, and drug products.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing.

Registered with FDA for: manufacture.