Immunomedics: Data integrity and quality issues cited in FDA 483

Dan Stanton, Managing editor

February 18, 2019

2 Min Read
Immunomedics: Data integrity and quality issues cited in FDA 483
Image: iStock/Richard Villalonundefined undefined

The US FDA found antibody-drug conjugate developer Immunomedics to have manipulated data during an inspection last year.

In January 2019, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Immunomedics for its antibody-drug conjugate (ADC) candidate sacituzumab govitecan, being developed to treat breast cancer.

The firm said at the time: “The issues related to approvability in the CRL were exclusively focused on Chemistry, Manufacturing and Control matters and no new clinical or preclinical data need to be generated.”


Image: iStock/Richard Villalonundefined undefined

But an inspection at Immunomedics’ drug substance facility in Morris Plains, New Jersey last August resulted in a Form 483 with 13 observations.

According to the heavily redacted inspection report, the firm’s quality unit lacked authority to investigate critical deviations of approved procedures.

“Specifically, the discovery of a data integrity breach in February 2018 did not trigger a deviation,” the Agency noted. “The scope of the data integrity breach included manipulation of bioburden samples, misrepresentation of the [redacted] integrity test procedures in the batch record and backdating of batch records, including dates of analytical results.”

The FDA added there is no assurance that samples and batch records from the process validation and commercial batches taken before February 2018 were not impacted by the data integrity breach.

Other observations cited by the Agency included inadequate raw material sampling, a lack of procedures for inventory audit trail and for tracking raw materials used in its manufacturing process, problems with the facility design, and issues with the cleaning and validating of production equipment.


No warning letter has been published but Immunomedics’ stock price dropped 27% following the announcement of the CRL to $13.12 per share.

A class action lawsuit has, however, been filed in the US District Court for the District of New Jersey on behalf of all persons or entities who purchased or otherwise acquired Immunomedics securities between August 23, 2018 and December 20, 2018.

“The complaint alleges that throughout the class period defendants made false and/or misleading statements, as well as failed to disclose material adverse facts,” New York-based law firm Bragar Eagel & Squire wrote in a statement. “Investors have until February 25, 2019 to apply to the Court to be appointed as lead plaintiff in the lawsuit.”

About the Author(s)

Dan Stanton

Managing editor

Journalist covering the international biopharmaceutical manufacturing and processing industries.

Founder and editor of Bioprocess Insider, a daily news offshoot of publication Bioprocess International, with expertise in the pharmaceutical and healthcare sectors, in particular, the following niches: CROs, CDMOs, M&A, IPOs, biotech, bioprocessing methods and equipment, drug delivery, regulatory affairs and business development.

From London, UK originally but currently based in Montpellier, France through a round-a-bout adventure that has seen me live and work in Leeds (UK), London, New Zealand, and China.

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