Drug factory · FDA FEI 1218978

Maine Oxy-Acetylene Supply Company

22 Albiston Way, Auburn, ME, United States

Problems found, fixed voluntarily at FDA's last inspection, Jul 27, 2016.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

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

What it does, for whom

Drug	Role	For	NDC
Carbon Dioxide	Makes it	Maine Oxy-Acetylene Supply Company	51887-200, 51887-302, 51887-402
Nitrogen	Makes it	Maine Oxy-Acetylene Supply Company	51887-001
Oxygen	Makes it	Maine Oxy-Acetylene Supply Company	51887-502, 51887-720

Ended	Result	Program	Problems noted
Jul 27, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	5
Dec 19, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jan 26, 2011	No problems found	Drug Quality Assurance	—

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

Records reviewed annually 21 CFR 211.180(e)
Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine inspection of equipment is not performed according to a written program designed to assure proper performance.
Management review - Lack of or inadequate procedures 21 CFR 820.20(c)
Procedures for management review have not been established.
Quality Audits - defined intervals 21 CFR 820.22
Quality audits were not performed to determine whether the quality system activities and results comply with quality system procedures.
Equipment control activity documentation 21 CFR 820.72(a)
Equipment have not been documented.

Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
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 and fully followed.
Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration and inspection of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.

Registered with FDA for: manufacture.