FDA 483 - Aspen Biopharma Labs Pvt., Ltd. - September 21, 2024

Aspen Biopharma Labs Pvt Ltd in Rangareddy, Hyderabad, India, was cited for significant deficiencies across its API manufacturing operations. The inspection revealed severe data integrity issues, a non-functional Quality Unit, inadequate process validation, and poor facility and equipment maintenance, exacerbated by recent flood damage and ongoing renovations. These findings indicate a pervasive lack of control over critical manufacturing processes and documentation.