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# Boehringer Ingelheim Inspection Report Posted
- URL: https://www.fdaweb.com/boehringer-ingelheim-inspection-report-posted/
- Published: 2024-10-30T12:00:00.000Z
- Updated: 2026-09-14T14:45:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158086

FDA has just posted the establishment inspection report issued following a 5/29-6/9/2023 inspection at the Boehringer Ingelheim drug manufacturing facility in Shanghai, China. The [report](https://www.fda.gov/media/183212/download?ref=fdaweb.com) says it covered the initial inspection of the facility and was limited to the manufacturing of a redacted drug substance and product in a specific building.

The seven inspection observations were:

- failure to have in writing and fully follow the responsibilities and procedures applicable to the firm’s quality unit;
- failure to establish and follow appropriate visual inspection procedures designed to assure batches of products meet appropriate specifications and statistical quality control criteria as a condition for their approval and release;
- failure to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failure to exercise appropriate controls to protect the electronic data acquisition and/or manufacturing control systems used for drug substance and drug product manufacturing;
- the current drug substance manufacturing practices present a high risk for potential contamination;
- failure to have written records of investigations into unexplained discrepancies, the failure of a batch or any of its components to meet specifications, to include appropriate conclusions and follow-ups; and
- failure of laboratory controls to include the establishment of scientifically sound and appropriate standards designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality, and purity.

An additional 11 investigator concerns were discussed with the firm’s management during the close-out meeting, FDA says.