FDA scolds Chinese firm for data integrity lapses, MIT for BIMO violations

The US Food and Drug Administration (FDA) has warned Chinese drugmaker Jiangsu Hengrui Pharmaceuticals for “serious data integrity violations” tied to shoddy record-keeping as well as lax contamination controls separating sterile from non-sterile processing areas.

The agency also sent a warning letter to the Massachusetts Institute of Technology’s Institutional Review Board (IRB) for violations of its informed consent procedures and documentation practices.

The warning letter to Jiangsu Hengrui followed a mid-January inspection of the company’s Lianyungang, China facility, during which investigators found “serious quality assurance (QA) deficiencies,” such as discarded original current good manufacturing practice (CGMP) records stacked in a bag underneath a vehicle and in a nearby trash can. Another problem was the production manager’s “unrestricted access to blank production batch records and other CGMP documents without QA issuance.”

When production employees reported an error in a record, the site’s production manager “printed a blank copy and had the employee transcribe the information on the new record and discarded the old record. There is no assurance that archived data is original or accurate.”

FDA said the company “failed to provide adequate oversight and ensure the reliability of data related to the quality of finished drug products manufactured at your facility.”

FDA also found inadequate controls to prevent contamination of sterile products, such as “inadequate physical separation between Grade A and Grade B classified areas” to separate sterile areas from non-sterile areas.

The site also failed to conduct smoke studies to demonstrate airflow between non-sterile Grade B areas and the sterile Grade A areas. FDA states that “thorough smoke studies are essential to evaluate and qualify your aseptic processing operations and ensure appropriate implementation of needed design remediations.”

According to a company website, its products had been marketed in “more than 40 countries” by the end of 2023. The company has received almost 20 approvals worldwide for injections, oral preparations, and inhalation anesthetics, including in the US, EU, and Japan. In addition, the company has recently entered into high-profile partnerships with Merck and biotech startup Hercules CM Newco.

Jiangsu Hengrui has 15 days to respond to the warning letter.

FDA finds problems with MIT’s IRB

Investigators with FDA’s Center for Biologics Evaluation and Research (CBER) found “objectionable conditions” related to MIT’s Committee on the Use of Humans as Experimental Subjects (COUHES) IRB oversight of patients participating in clinical investigations.

The warning letter was posted on 16 July following a Regulatory Assessment (RRA) conducted in May and June 2024. Investigators said MIT failed to disclose to subjects the availability of alternative procedures or courses of treatments that might benefit the subjects in violation of regulations under 21 CFR 50.25.

The informed consent forms also did not explain whether any compensation is available if injuries occur related to the trials as required under 21 CFR 50.25(a)(6).

Further, the IRB also failed to prepare accurate meeting minutes; FDA said the number of voting members in the meeting minutes did “not match the number of members documented in the minutes as having voted on IRB actions during convened meetings.”

It was also unclear from the meeting minutes “when members entered the meeting, exited, or excused themselves or disconnected from the Zoom platform when remote meetings were held.”

The IRB also failed to disclose the IRB members’ earned degrees, representative capacity, or experience including board certifications and licenses.

The IRB has 15 days to respond to the letter.

Jiangsu Hengrui warning letter; MIT warning letter

FDA scolds Chinese firm for data integrity lapses, MIT for BIMO violations

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