Drug factory · FDA FEI 3016419927

TOYO Pharmaceutical Co., Ltd.

2-5-4, Tsurumi, Tsurumi-ku, Osaka, Japan

Problems found, fixed voluntarily at FDA's last inspection, Jun 16, 2023.

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 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Sirolimus	Makes it and tests it	Nobelpharma America, LLC	73683-101

Ended	Result	Program	Problems noted
Jun 16, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	2

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

Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded and justified.
Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the packing of a drug product lack the training required to perform their assigned functions.

Registered with FDA for: analysis; label; manufacture.