Drug factory · FDA FEI 3011682

Oxarc, LLC

716 S Oregon Ave, Pasco, WA, United States

Problems found, fixed voluntarily at FDA's last inspection, Jan 11, 2018.

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 2018: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Ended	Result	Program	Problems noted
Jan 11, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	4

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

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations.
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 and packing of a drug product lack the training required to perform their assigned functions.

Registered with FDA for: manufacture.