FDA 483 - Ungerer & Co - June 05, 2024

Ungerer and Company, an API manufacturer in Bethlehem, PA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to validate manufacturing processes, lacked adequate written procedures for equipment qualification, cleaning, and process controls, and did not perform required stability testing or annual product reviews for its Camphor Powder Synthetic USP drug substance. These issues indicate a systemic lack of control over critical aspects of drug substance manufacturing and quality assurance.