Drug factory · FDA FEI 3005178720

Medical Equipment Solutions Inc dba Pur Air Products

1220 Vernon St., North Kansas City, MO, United States

Problems found, fixed voluntarily at FDA's last inspection, May 16, 2016.

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 2011: 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	Medical Equipment Solutions Inc dba Pur Air Products	72660-001

Ended	Result	Program	Problems noted
May 16, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	4
Feb 24, 2011	Problems found, fixed voluntarily	Drug Quality Assurance	—

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

Record maintenance 1 year (except exempt OTC) 21 CFR 211.180(b)
All records of production associated with a batch of drug product are not maintained at least one (1) year after the expiration date.
Identification of Equipment and Lines 21 CFR 211.188(b)(2)
The batch production and control records are deficient in that they do not include the identity of major equipment used.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records.

Registered with FDA for: manufacture.