FDA Warns Chinese Drug Manufacturer for Limiting Inspection, Systemic Data Manipulation
The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Beijing Taiyang Pharmaceutical Industry Co. on 19 October after the company limited FDA’s ability to conduct an inspection and manipulated manufacturing data.
The warning letter follows FDA adding the company to two import alert lists in April, effectively halting its ability to ship products to the US.
Barred Entry to Warehouse
On 16 November 2015, FDA investigators observed through a window of the facility’s warehouse numerous drums bearing the company’s label, but when FDA investigators requested access, the company “barred them from entering the warehouse to examine the containers or the material in them without giving a reasonable explanation.”
The following day, FDA says its investigators did gain access to the warehouse but upon entry, “they observed that a significant number of drums had been removed and were not available for inspection. When they asked about the drums they had observed the previous day, you provided no explanation of the whereabouts or contents of the drums.”
Data Manipulation
In addition, FDA said its investigators observed “systemic data manipulation” across the Beijing facility, with unexplained deletions of laboratory test results, a reliance on falsified and manipulated test results to support batch release and stability data, as well as routine re-testing of high performance liquid chromatography (HPLC) samples and deleted previous chromatograms without justification.
The company told FDA that the results of repeated tests were deleted to decrease the number of saved chromatograms on its hard drives.
But FDA says: “Any data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria and maintained for CGMP purposes. In order to exclude data from the release criteria decision-making process, you must have valid, documented, scientific justification for its exclusion… Reducing the number of records on your hard drives is not a sufficient justification for excluding data.”
FDA investigators also witnessed an employee backdating production batch records for seven batches of one active pharmaceutical ingredient, and a laboratory analyst attempted to remove a large pile of loose documentation from the HPLC instrumentation room.