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FDA inspectors found mold and insects at two Chinese GLP-1 ingredient plants

Both Chengdu Shengnuo Biopharm and Nanjing Chengong Pharmaceutical were placed on the FDA import alert list after the inspections.

DO
By Daniel Okafor · Regulatory Correspondent
Oct 15 18:21 ETSource: New York Post

The wire

  1. 01Bloomberg reported FDA inspectors found moldy floors and bugs in the ceiling at Chengdu Shengnuo Biopharm, with staff pouring out samples and moving documents into lockers as inspectors arrived.
  2. 02The plants supplied semaglutide and tirzepatide ingredients used in unapproved copies; buyers of compounded or gray-market product cannot verify source quality.
  3. 03At Nanjing Chengong, staff allegedly applied their own approval seal to ingredients made elsewhere without reviewing testing records; the drugs themselves were not tested, and Chengdu Shengnuo said it is implementing corrective measures.

From the source

FDA inspectors found bugs, mold at two Chinese factories that make GLP-1 weight-loss drugs: report

Inspectors at the Food and Drug Administration found “gross contamination” at two factories in China that make components for GLP-1 weight-loss drugs — including mold and bug infestations, according to an explosive report.

Read at nypost.com
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