China Facility Limits FDA Inspection

FDA issued a warning letter, dated Oct. 19, 2016, to Beijing Taiyang Pharmaceutical Industry Co. for limiting or refusing an FDA inspection and violations of current good manufacturing practices (CGMP). Specifically, FDA cited the company for data integrity issues. The violations prompted the agency to place the firm on Import Alerts 99-32 and 66-40 on April 28 and April 29, 2016, respectively.

The warning letter follows a November 2015 inspection of the company’s Beijing facility. Initially, when inspectors arrived on November 16, 2015, company representatives barred FDA investigators from entering a warehouse containing drums the investigators observed through a window. The company allowed investigators to enter the warehouse the following day; however, many drums appeared to have been removed from the building. No explanation about where the drums were or what they contained was provided to FDA.

FDA stated in the letter that investigators also observed data manipulation throughout the facility that included unexplained deletions of laboratory test results. According to the agency, the company repeated tests until acceptable results were obtained, and out-of-specification results were not investigated by the company. The company responded to the agency that some deletions were done to limit space on hard drives. FDA responded, saying, “Reducing the number of records on your hard drives is not a sufficient justification for excluding data. Your response is inadequate because you have not shown how you will correct the data manipulation and falsification practices discussed above, nor have you demonstrated how you will ensure that all CGMP test results are retained and considered by your quality unit as a part of batch release.”

The company also failed to record all quality related activities at the time they were performed and failed to maintain batch production and laboratory control records to determine compliance with specifications before a batch was released. It appeared that analyses were performed on batches of product after the company had supposedly stopped production on that product.

In the letter, FDA stated, “Your response reiterates that your company did not manufacture (b)(4) API batches with batch numbers of (b)(4) through (b)(4) and the test results that our investigators reviewed and asked about during the inspections were from old samples and tests performed for training purposes. Your response is inadequate because you did not explain how analyses for non-existent batches could be labeled with official unique batch numbers, nor did you explain how your laboratory control system permits the exclusion of analytical results, whether for training or other reasons, without justification.”

FDA recommended the company perform a comprehensive investigation of its inaccurate data records. It also suggested that a risk assessment of the potential effects of the failed data integrity on product quality be performed. The implementation of a corrective action and preventive action plan was also suggested.

Source: FDA