1. The relevant product of the Defendant against the Plaintiff on January 6, 2017 on the part of the Plaintiff, for three months, on the part of the Plaintiff.

Details of the disposition

The plaintiff is engaged in the manufacture and sale of drugs, non-pharmaceutical products, etc., and is manufacturing and selling Lebagsan, Lebagsan, etc.

On November 25, 2016, the Defendant shall conduct a special pharmacist surveillance (hereinafter “instant special pharmacist surveillance”) with respect to the Plaintiff’s factory (hereinafter “instant factory”) and confirmed the violation of the false preparation of a record at the workroom where the arching process for Lebasan and Lebasan is in progress, and confirmed the violation of Article 38(1) of the Pharmaceutical Affairs Act, Article 48(2) of the Regulations on the Safety of Drugs, Etc. (hereinafter “instant Rules”), Article 76(3) of the Pharmaceutical Affairs Act, Article 95 and attached Table 8 of the instant Rules [Attachment 8]

Ⅱ With respect to the suspension of manufacturing operations of the relevant product for three months in relation to Legnasan, Legnasan, and Legnasan under subparagraph 25(c)(ii) of individual standards (hereinafter “instant suspension”).

A) At the time of the Special Pharmaceutical Surveillance, the Defendant, who did not have any dispute, entered Gap evidence Nos. 1 and 2, Eul evidence Nos. 2, and the purport of the entire pleadings, was entitled to the disposition of this case as to the legitimacy of the disposition of this case, is entitled to the disposition that the Plaintiff prepared a false indoor temperature in the record of the manufacture on the basis that the temperature in the factory of this case was exceeded the temperature standard work method (Svise-to-door Control, SOP) at the time of the Special Pharmaceutical Surveillance Surveillance.

However, the plaintiff's employee measured and stated the internal temperature at the time of the commencement of the Scting room work, and there was no false statement in the internal temperature at the time.

At the time of the Special Pharmaceutical Monitoring Date of this case, there is room for an increase in internal temperature due to the entry into the Scaming room in which the pharmaceutical inspectors and the employees of the plaintiff were 10 mnife at the same time, and for this reason, the possibility that the temperature in the Scaming room was temporarily deviated from the standard temperature section cannot be ruled out.

This case’s special pharmacist surveillance.