FDA 483 - ENDO Pharmaceuticals Solutions, Inc. - October 23, 2018

ENDO Pharmaceuticals Solutions, Inc. in Cranbury, NJ, received a Form 483 with five observations highlighting significant deficiencies. The inspection revealed issues in preventing microbiological contamination, maintaining aseptic processing areas, and ensuring adequate laboratory controls for product testing. Additionally, the firm failed to thoroughly investigate out-of-specification results for drug product components, which were linked to patient complaints for distributed implant lots.