FDA 483 - Bachem Americas, Inc. - November 20, 2018

Bachem Americas, Inc. was cited for multiple quality system deficiencies during an FDA inspection. Observations included untimely review and approval of quality investigation documents, late annual product reviews, and overdue preventive maintenance on production equipment. Additionally, the firm failed to conduct timely supplier and contract laboratory audits and exhibited deficiencies in batch record completeness and data security for analytical equipment.