FDA 483 - SLV Pharmaceuticals LLC - April 14, 2022

SLV Pharmaceuticals LLC, a drug product manufacturer in Hauppauge, NY, was cited for significant deficiencies in its manufacturing and quality control processes. Observations included a lack of process validation, inadequate stability testing for expiration dates, deficient equipment cleaning procedures, and improper storage conditions for drug products and APIs. The firm also failed to conduct required annual product reviews.