SQA

AUGUST 8, 2023

Additional concerns were noted with respect to: Temperature/humidity controls Calibration inspection and/or qualification of equipment, including computerized systems Equipment usage logs Release of finished products Change Control Records Quality Agreement(s) Specifications for finished products Retention samples Bausch Health, Canada Inc.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 8, 2023

Additional concerns were noted with respect to: Temperature/humidity controls Calibration inspection and/or qualification of equipment, including computerized systems Equipment usage logs Release of finished products Change Control Records Quality Agreement(s) Specifications for finished products Retention samples Bausch Health, Canada Inc.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 1, 2024

Companies participating in the program will receive annual audits to monitor the risk and verify the maintenance of compliance with GMP, contributing to the control of the health risk of the products. Non-Compliance Rating for Upmaid Technologies Inc., This indicated a lack of proper implementation of the necessary CAPAs.

FDA 40

FDA Licensing Compliance World Health 40

SQA

FEBRUARY 15, 2023

A new template for the Certificate of a Pharmaceutical Product will be put into use in line with China’s pharmaceutical export practices and the latest World Health Organization (WHO) guidelines. The electronic certificate and the paper version are equally authentic.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

SQA

MAY 6, 2025

SQA Regulatory Surveillance Summary for 3Q/4Q 2024 By: Laurel Hacche and Debra Cortner As we move through 2025, looking back at regulatory updates from Q3 and Q4 of 2024 provides critical insight into how the global compliance landscape is evolving. However, in practice, the NMPA expects compliance with industrial standards.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Compliance Licensing 52

SQA

DECEMBER 16, 2022

China’s Center for Medical Device Evaluation (CMDE) Update Compliance Guidelines and Recommended Paths for Clinical Evaluation Paths for Certain Medical Devices, 25 July 2022. 29 of 2022 , Technical Guidelines for Compliance with the Essential Principles of Medical Device Safety and Performance. CMDE Announcement No.

FDA 40

FDA Compliance COVID-19 Licensing 40

SQA

OCTOBER 18, 2023

The following is a summary of a Canadian case report that was evaluated by Health Canada, describing an error associated with confusion about the labelled strength of a mineral supplement: In this case, the prescription was dispensed by the pharmacy using a product labelled as Calcium Carbonate 500 mg. As a result, the patient received 2.5

FDA 40

FDA Compliance Licensing World Health 40