FDA 483 - BELOTECA INC - August 29, 2025
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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.
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ID · 3f7edcfc-de99-4da5-baf0-d1cf794b06e9