Issued: 2/8/12
Region: Southeast
Category: Drug 483s
Inspection date range: 1/30/12-2/8/12
Pages: 4
Company: Shionogi, Inc.
5770 Shiloh Rd.
Alpharetta, GA 30005
Inspector(s): Lareese K. Thomas, Trang N. Cox
Observations: The responsibilities and procedures applicable to the quality control unit are not fully followed.