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FDA: More Warning Letters for Lack of Data Integrity

In 2017, the US FDA has already listed the impressing number of 73 Warning Letters on its website. One topic that emerges again and again is the violation of data integrity, with rising tendency. Remarkably often, those violations are found in China and India. This time, the following pharmaceutical manufacturers are involved:

  • USV Private Limited, Daman, India
  • Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City, China.

Warning Letter to USV Private Limited, Daman, India

The written warning to USV, dated 10 March 2017, summarizes significant violations of CGMP regulations for finished pharmaceuticals. The FDA lists the following findings:

  • The firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity.
  • USV failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
  • The firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.
  • The firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards.

These violations were already found at multiple company sites, e.g. in Mumbai. The FDA states that these repeated problems demonstrate that the company’s oversight and control over manufacture of drugs is inadequate. There should be an immediate and comprehensive assess to the company’s global manufacturing operations to regain conformity with FDA requirements.


Warning Letter to Jinan Jinda Pharmaceutical Chemistry Co., Zhangqiu City, China

Already in February 2017, Jinan Jinda, a Chinese API-manufacturer in Zangqui City, received a FDA-warning letter for significant violations of CGMP for APIs. The deviations observed by the FDA include:

  • The failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP, and meet established specifications for quality and purity.
  • The failure to adequately investigate out-of-specification results.
  • The failure to prevent unauthorized access or changes to data, and failure to provide adequate controls to prevent omission of data.

In more detail the FDA writes: “Our investigator observed that your laboratory systems lacked controls to prevent your staff from altering or deleting electronic data. Analysts manipulated and deleted audit trails. You lacked adequate controls for all HPLC, gas chromatography, and ultra-violet systems. For example, an analyst deleted audit trails in your gas chromatography equipment #YQ-07-10 from September 15, 2015, through April 24, 2016, and permanently deleted audit trails from November 6 to 13, 2015. In addition, our investigator observed that your quality control manager and quality control deputy manager had full administrative rights on all of your computerized systems, which allows them to manipulate data and turn off audit trails.”

A comprehensive to-do-list is now waiting for Jinan Jinda to be fulfilled.The FDA already placed the firm on Import Alert on November 25, 2015. The question remains what has been changed since then.

FDA: Warning Letters




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