FDA Inspection 961508 - Sato Pharmaceutical Co., Ltd. - February 12, 2016

FDA Inspection 961508 for Sato Pharmaceutical Co., Ltd. on February 12, 2016. Classification: Official Action Indicated (OAI).

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Record Summary

FDA Inspection 961508 for Sato Pharmaceutical Co., Ltd. on February 12, 2016. Classification: Official Action Indicated (OAI).

Violation Codes

21 CFR 211.113(b)

21 CFR 211.194(a)(2)

21 CFR 211.194(c)

21 CFR 211.42(c)(10)(iii)

21 CFR 211.42(c)(10)(iv)

21 CFR 211.80(b)

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Record Information

Company

Sato Pharmaceutical Co., Ltd.

Inspection Date

February 12, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

ID: 7220a26f-ea4c-4152-b9aa-a7142357e82f

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