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Article: Cleaning validation expected to be complete by year's end, patched screens discontinued. (Human drugs).(Bachem California )
- Article from:
- Validation Times
- Article date:
- July 1, 2002
- Author:
CopyrightCOPYRIGHT 2002 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Cleaning validation residual studies at active pharmaceutical ingredient (API) manufacturer Bachem California are expected to be completed by the end of the year, the firm said in response to FDA's Jan. 14 warning letter. FDA acknowledged the company's Dec. 12 response to the 483 issued Nov. 27, 2001, but commented that, in several instances, the responses were either inadequate or lacked documentation.
While Los Angeles District Director Alonza Cruse initially called the firm's end-of-2002 completion date "not justified" in his warning letter (Doc. 11367W), the agency changed its tune in a Jan. 31 letter to the firm from District Compliance Officer Dannie ...