FDA 483 - Pharmascience Inc. - February 13, 2024

An FDA inspection of Pharmascience Inc., a manufacturer of sterile and non-sterile drug products, revealed significant deficiencies in quality control processes. The firm failed to thoroughly investigate out-of-specification results and customer complaints, leading to the release of potentially non-conforming products. Additionally, procedures for preventing microbiological contamination of sterile products were inadequate, and the stability testing program was not followed.