FDA 483 - MFCI (Huanggang) Co., Ltd. - August 14, 2017

The FDA inspection of MFCI (Huanggang) Co., Ltd. in Huanggang, Hubei, China, revealed significant data integrity issues, including deleted laboratory records and inadequate computer controls. Numerous deficiencies were also found in equipment maintenance, process validation, environmental controls, and quality control procedures for API manufacturing. These observations indicate a systemic lack of adherence to cGMP requirements, posing a risk to product quality and patient safety.