Drug factory · FDA FEI 3003414080

Linde Gas Equipment Inc.

1575 Candelaria Rd Ne, Albuquerque, NM, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 14, 2012.

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 2012: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Sep 14, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	6

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.
Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
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.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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.

Registered with FDA for: manufacture.