Drug factory · FDA FEI 3001451496

Middlesex Gases &Technologies, Inc.

292 2nd St, Everett, MA, United States

No problems found at FDA's last inspection, Apr 7, 2014.

No Action Indicated: inspectors found no objectionable conditions.

2 drug inspections on record since 2011: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Carbon Dioxide	Makes it	Middlesex Gases and Technologies, Inc.	63961-010
Nitrogen	Makes it	Middlesex Gases and Technologies, Inc.	63961-200
Oxygen	Makes it	Middlesex Gases and Technologies, Inc.	63961-100

Ended	Result	Program	Problems noted
Apr 7, 2014	No problems found	Drug Quality Assurance	—
Oct 28, 2011	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.

Running water at suitable temperature 21 CFR 110.37(e)
Hand-washing facilities lack running water of a suitable temperature.
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.
Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
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.

Registered with FDA for: manufacture.