FDA 483 - Speciality Pharma Manufacturing, LLC - March 16, 2020

Speciality Pharma Manufacturing, LLC, an OTC drug product manufacturer in Carlstadt, New Jersey, was cited for significant deficiencies in its production and process controls. The firm lacked written procedures and had not conducted process validation for several OTC drug products, including HURRICAINE® and CEO-TWO®. Furthermore, two batches of CEO-TWO® that failed assay specifications were released to a customer and subsequently distributed in the U.S.