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Regulatoryfdabaxterolympuswarning letters

RAPS weekly roundup flags FDA peptide dispute and new warning letters

The regulatory roundup cites GMP and Quality System Regulation violations at Baxter International and Olympus Medical Systems.

DO
By Daniel Okafor · Regulatory Correspondent
Oct 23 17:20 ETSource: RAPS

The wire

  1. 01RAPS reported that FDA sent warning letters to Baxter International and Olympus Medical Systems over good manufacturing practice and Quality System Regulation violations.
  2. 02The same roundup lists a peptide dispute and clinical trial legislation among the week's agency items, both of which bear on compounders and sponsors.
  3. 03Details of the peptide dispute are not set out in the available roundup text; readers should check the agency's own postings for specifics.

From the source

This Week at FDA: Peptide dispute, clinical trial legislation, and more

The US Food and Drug Administration (FDA) sent warning letters to two major healthcare product manufacturers—Baxter International and Olympus Medical Systems—for good manufacturing practice (GMP) and Quality System Regulation (QSR) violations.

Read at raps.org
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