Exeed Regulatory Compliance

MARCH 5, 2020

Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency. The World Health Organization (WHO) has stopped short of classifying the outbreak as a pandemic, but consistently encouraged affected countries to activate their national emergency response plans.

US Department of Health and Human Services 52

US Department of Health and Human Services FDA Public Health COVID-19 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 52

FDA Compliance Public Health World Health 52

SQA

OCTOBER 18, 2024

Level 2: When a simplified analysis of the EFRA inspection report is performed to evaluate compliance with the GMP requirements and may be adopted unilaterally by ANVISA. The classification criteria include: Serious deficiencies: Typically linked to non-compliance with critical items. Major deficiencies: Associated with major items.

FDA 40

FDA Compliance Public Health Governance 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 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

JUNE 3, 2024

A health professional, in the context of a directed donation, did not create a document stating that, in their medical opinion, the use of sperm or ova would not pose a serious risk to human health and safety. Now the Ministry of Health has published revised regulations in accordance with Annex M of the Drugs and Cosmetics Rules.

FDA 40

FDA COVID-19 Licensing Nurses 40