Bioptimal International

Warning LetterOpen

ChinaFEI 3016261803Issued Apr 3, 2024OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3016261803.

Violations0

Issue DateApr 3, 2024

Product TypeDevices

StatusOpen

Letter Details

Firm: Bioptimal International
Location: China
FEI Number: 3016261803
Country: China
Issue Date: April 03, 2024
Issuing Office: OHT2: Office of Cardiovascular Devices, Office of Product Evaluation and Quality
Product Type: Devices
Status: Open

Summary

Based on limited metadata, Bioptimal International, a medical device company, received an FDA Warning Letter on April 3, 2024. While the specific violations cannot be determined due to unavailable subject line and letter details, the warning indicates regulatory concerns with one or more of the company's device products. Without access to the full letter text or issuing office designation, the precise nature of the compliance issues and their regulatory scope cannot be specified from this metadata alone.

Bioptimal International FDA Warning Letter, April 3, 2024