FDA 483 - BELOTECA INC - August 29, 2025

BELOTECA INC in San Diego, CA, was inspected from August 25-29, 2025, and received a Form 483 with three observations. The inspection revealed significant deficiencies in post-marketing surveillance, including a lack of written procedures for adverse drug experiences and the late submission of multiple periodic adverse drug experience reports and annual reports for their combination products. These issues indicate a failure to comply with regulatory reporting requirements.