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# Lumis Inspection Finds CGMP Deviations
- URL: https://www.fdaweb.com/lumis-inspection-finds-cgmp-deviations/
- Published: 2017-03-14T12:00:00.000Z
- Updated: 2026-09-14T22:11:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138194

A 9/26-9/28/16 FDA inspection at Lumis Global Pharmaceuticals, Wuhan, China, found significant deviations from current good manufacturing practices (CGMP) for active pharmaceutical ingredients (API), according to a 3/2 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545464.htm?ref=fdaweb.com). Specific deviations cited in the letter include: 

- failure to transfer all quality or regulatory information received from the API manufacturer to Lumis’ customers;
- failure to control the API repackaging, relabeling, and holding operations to avoid mix-ups and loss of API identity; and
- failure of the firm’s quality unit to exercise its responsibility to ensure the API relabeled at its facility comply with CGMP.

The letter says the firm’s gabapentin API is misbranded because its labels indicate that Lumis is the manufacturer instead of its unidentified supplier. It also says that one of Lumis’ suppliers has been on import alert, but Lumis shipped unidentified API manufactured by that firm to the U.S. in 2/2015 and declared that it was the manufacturer on importation documents.

FDA recommends the firm retain a consultant qualified to evaluate its operations and assist in meeting CGMP requirements.

FDA placed Lumis on import alert 2/15 and told the company to respond with **(1)** written procedures for transferring quality and regulatory information, including information sent to customers; **(2)** a plan to establish, document, and implement an effective system for managing quality including written procedures for CGMP-related activities and the roles of personnel responsible for oversight; and **(3)** specific actions taken since the inspection to correct the deviations and prevent their recurrence, with a timetable for completion.