FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co. Ltd - May 13, 2016

This FDA Form 483 was issued to Hubei Gedian Humanwell Pharmaceutical Co. Ltd, located at 25 Gedian Road, Gedian Economic Development Zone, Ezhou, Hubei, China 436000. The inspection, conducted from May 9 to May 13, 2016, by Alice S. Lee, CSO, identified the firm as a Finished API and Intermediate Manufacturer.

Two observations were noted: 1. **Observation #1:** The facility failed to adequately calibrate a (b)(4) according to actual operating conditions. This indicates a potential issue with the accuracy and reliability of equipment used in manufacturing or quality control processes. 2. **Observation #2:** The firm failed to conduct (b)(4) cleaning in both Sampling Room #1 and #2 as per their own Standard Operating Procedure (SOP) #MVM-019(04), titled "Sampling Room and Sampling Booth Management Procedures," effective November 13, 2015. This suggests a deviation from established cleaning protocols, which could impact product quality and prevent contamination.

These observations highlight deficiencies in equipment calibration and adherence to established cleaning procedures, indicating potential issues within the firm's quality system and manufacturing controls.