News & Analysis as of

Inspections Compliance Monitoring

Oberheiden P.C.

How to Handle an EPA Inspection: Tips for Success and Mistakes to Avoid

Oberheiden P.C. on

The United States Environmental Protection Agency (EPA) has long conducted inspections to assess the efficacy of companies’ environmental compliance programs. However, under the EPA’s Climate Enforcement and Compliance...more

Goodwin

Common FDA Bioresearch Monitoring (BIMO) Violations: Updates from FY 2023 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

Goodwin

Form FDA 483 Response Best Practices Announced by the FDA

Goodwin on

In Draft Guidance published this week by the U.S. Food and Drug Administration (FDA), Guidance for Industry – Processes and Practices Applicable to Bioresearch Monitoring Inspections, the Agency provides some wisdom on best...more

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