FDA WARNING_LETTER - Lyne Laboratories, Inc. - October 05, 2007

On January 17, 2008, the FDA issued a Warning Letter to Lyne Laboratories, Inc. following an inspection from September 20 to October 5, 2007, which revealed significant deviations from CGMP regulations (21 CFR Part 211) for finished pharmaceuticals. These deviations render the firm's products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to thoroughly review batch failures (21 CFR § 211.192):** Lyne Laboratories has not completed an investigation into the chemical composition and patient risk of particulate matter in Calcitriol Injection, an issue previously noted in December 2005. The firm continues to observe visible particulates post-100% visual inspection. 2. **Inadequate laboratory controls (21 CFR § 211.160(b)):** The firm's quality control criteria are insufficient to ensure removal of all ampoules with visible particulates or charring. The 100% visual inspection process for Calcitriol product has not been validated to demonstrate its effectiveness in removing defective ampoules.

While the firm's November 6, 2007, response to the FDA-483 acknowledged efforts and committed to revising specifications, the FDA deemed the response unsatisfactory regarding the