Drug factory · FDA FEI 3004067672

Linde Gas & Equipment Inc.

50 D'Angelo Drive, Bldg 1, Marlborough, MA, United States

Problems found, fixed voluntarily at FDA's last inspection, Feb 18, 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 2012: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Feb 18, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	4
May 29, 2012	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.

Written procedures followed 21 CFR 211.186(a)
Procedures for the preparation of master production and control records are not followed .
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed .
Lack of quality control unit 21 CFR 211.22(a)
There is no quality control unit.
Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance and receipt and evaluation and reporting to FDA of post marketing adverse drug experiences.

Expiration date lacking 21 CFR 211.137(a)
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Registered with FDA for: manufacture.