FDA sent a warning letter, dated Sept. 7, 2017, to Wuxi Medical Instrument Factory after an inspection of the company’s No. 43 Xixin Road, Zhangjing, Xibei Town, Wuxi City Jiangsu, China facility, conducted March 6–10, 2017. The warning letter details current good manufacturing practice (CGMP) violations that include deficient validation, batch record, and equipment cleaning procedures.
During the March 2017 inspection, FDA investigators found that the company had not adequately validated its process for manufacturing product. The company could not provide FDA officials with process qualification batch records and quality control documents. “You provided only a protocol and a summary report with insufficient data. Batch records for your commercial product also failed to document all significant process parameters (e.g., (b)(4) times), order of ingredient addition, sampling frequency, and sample size. You lacked assurance that in-process materials and finished drug products met predetermined manufacturing and quality requirements,” the agency stated.
FDA asked the company to provide a data-driven program to identify and control sources of variability. The agency also asked for revised procedures for a monitoring process control program and an updated master batch record.
The company also failed to establish appropriate laboratory controls, according to FDA. “You did not perform growth promotion testing on each batch of microbiological growth media you prepare for settle plate, bioburden, and sterility testing. In addition, you do not have a written procedure to ensure that prepared media consistently meets appropriate standards of quality and purity,” the agency stated. FDA is asking the company to provide procedures for ensuring “that media used for settle plate, bioburden, and sterility testing is prepared consistently and promotes microbial growth.”
Equipment cleaning and maintenance were also found to be lacking at the facility. Equipment and utensils were not appropriately cleaned or sterilized to prevent malfunction or contamination. In addition, documentation regarding equipment maintenance was deficient. The company was asked to provide FDA with an investigation into data integrity issues, a risk assessment on the quality of its products, and a management strategy for corrective actions and preventive actions.