Marian Meyer, Author at Lachman Consultant Services, Inc.

FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol

By Marian Meyer Feb 20, 2024 ANDAs Biologics Biosimilars BLA Generics NDA OTC Regulatory Affairs

In 2022, there were six Warning Letters and five 483 observations for issues relating to Diethylene Glycol (DEG) and Ethylene Glycol (EG). In 2023, there were thirty-six Warning Letters and nineteen 483 observations for DEG and EG concerns. So far this year (mid-February 2024), there have already been three Warning Letters containing observations for DEG […]

Mar

What The FDA Doesn’t Tell You About OOS Investigations for Raw Materials

By Marian Meyer Mar 15, 2023 API FDA OOS Quality

The FDA guidance “Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production Guidance for Industry” (May 2022) (here) applies to APIs and other raw materials, as well as finished products, but does not address specific considerations for APIs and excipients. Here at Lachman, we work with manufacturers of multiple product types and have the following advice […]

FDA Goes Back to Basics with Multiple Observations for Diethylene Glycol and Ethylene Glycol

What The FDA Doesn’t Tell You About OOS Investigations for Raw Materials

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