Drug factory · FDA FEI 3010165779

First Community Care, LLC

3404 Metro Dr. N Ste D, Fort Wayne, IN, United States

Problems found, fixed voluntarily at FDA's last inspection, Apr 16, 2015.

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 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Oxygen	Makes it	First Community Care	63121-123

Ended	Result	Program	Problems noted
Apr 16, 2015	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.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions.
Sampling and testing plans not followed 21 CFR 211.165(c)
Written procedures for sampling and testing plans are not followed 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 fully followed.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training required to perform their assigned functions.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt, testing, and approval of components.

Registered with FDA for: manufacture.