FDA EIR - Tolmar, Inc. - December 06, 2017

An FDA inspection was conducted at TOLMAR, Inc., Fort Collins, CO, from November 28 to December 6, 2017. This comprehensive inspection, guided by Good Manufacturing Practice (cGMP) regulations and QSIT Level I for combination products, covered the company's sterile injectable and non-sterile human drug manufacturing, including the combination drug-device product ELIGARD. The regulatory framework encompassed sterile and non-sterile human drug process inspections, animal drug manufacturing, and medical device manufacturing compliance programs.

The inspection identified two main violations, documented in an FDA Form 483. First, the company failed to establish appropriate controls for its integrity tester, specifically lacking separate user accounts and a formal procedure for electronic data and audit trail review. Second, supplier certificates of analyses for critical raw materials, leuprolide acetate and nitrogen, were not periodically verified for all required specifications. The inspection also noted a late submission of a Field Alert Report, despite previous similar issues being addressed. TOLMAR, Inc. acknowledged the deficiencies and committed to providing a written response to the FDA within fifteen business days, outlining their corrective actions. The firm is currently registered as an FDA drug manufacturer.