The regulatory pressure on the Radnor-based company intensified on June 2, 2026, when the FDA disclosed a warning letter citing significant breaches of Good Manufacturing Practice regulations. Regulators specifically flagged the company's inability to investigate unexplained batch failures, microbial contamination, and inadequate cleaning protocols. This marked the second time in two months that the company faced such scrutiny, according to reports from Reuters.

Financial performance has mirrored these operational setbacks. The company’s share value dropped 7% immediately following the initial disclosure of the FDA violations. A further 12% decline occurred on August 5, 2026, after the company reported its second-quarter results and issued a downward revision of its full-year adjusted EBITDA guidance. Investors seeking to discuss potential legal recourse regarding these losses are being directed to contact attorney Jonathan Naji at (484) 270-1453.