FDA EIR - Cheng Fong Chemical Co., Ltd. Dayuan Factory - April 14, 2017

An FDA follow-up inspection of Cheng Fong Chemical Co. Ltd. in Taoyuan City, Taiwan, was conducted from April 10-14, 2017. This inspection aimed to verify the implementation of corrective and preventive actions following a previous warning letter (320-16-33) and evaluate current Good Manufacturing Practices (GMP) for bulk active pharmaceutical ingredients. The inspection was guided by Compliance Program Guidance Manual 7346.002F and ICH Q7A. The inspectors identified significant deficiencies, resulting in a five-item FDA Form 483. Recurring issues from the prior inspection included inadequate production equipment maintenance and cleaning that was not scientifically justified. New observations highlighted a lack of Quality Unit oversight in document control and review, as well as insufficient laboratory control procedures and incomplete laboratory records. Specific issues involved equipment in a 'clean' status still containing product residue, corrosion, and debris, along with undocumented visual cleaning verification. The Quality Unit also showed poor control over document shredding practices and calculation verification, leading to potential data integrity concerns. During the inspection, the company also refused photography in manufacturing areas. Management was informed that a written response to the FDA 483 is required within fifteen business days to address these observations.