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# 3 Observations in Lonza Guangzhou FDA-483
- URL: https://www.fdaweb.com/3-observations-in-lonza-guangzhou-fda-483/
- Published: 2026-01-07T12:00:00.000Z
- Updated: 2026-09-14T15:30:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160445

FDA has released the form FDA-483 issued following a 10/27-10/31/2025 inspection at the Lonza Guangzhou Pharmaceutical active pharmaceutical ingredient manufacturing facility in Nansha District, Guangzhou, Guangdong, China. The three specific inspection observations were:

- failure to fully follow responsibilities applicable to the quality unit;
- failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed; and
- the quality system that approves contract laboratories to perform testing of redacted impurities is deficient.