Alembic Pharmaceuticals Receives USFDA Form 483 with Five Observations at Jarod Facility

Alembic Pharmaceuticals Ltd. has recently undergone a scheduled GMP inspection by the United States Food and Drug Administration (US FDA) at their Solid Oral Formulation Facility (F-4) located at Jarod. The inspection took place from 14th November 2024 to 22nd November 2024. The USFDA has issued a Form 483 with five procedural observations. The company has committed to providing a comprehensive response to the US FDA for these observations within the stipulated period. Alembic Pharmaceuticals is dedicated to maintaining the highest quality standards and compliance at all times.