Drug Manufacturer Recklessly Disregards Manufacturing Deficiencies


FDA Compliance Expert WitnessThis case involves a securities class action claim against a US-based drug manufacturer. The claim focuses on the company’s failure to properly convey information pertaining to warning letters issued by the FDA to its shareholders. The company operates manufacturing facilities in California and Taiwan. Apart from what defendants learned from the FDA, it is alleged that they independently knew or recklessly disregarded the fact that the company had significant, pervasive manufacturing and quality control deficiencies. It is also alleged that they had no reasonable basis to assure investors that the company was capable of clearing the warning letter in a timely manner. The expert needed for this case is someone who is intimately familiar with FDA gCMP and NDA policies, and must be able to review documentation related to the plaintiffs’ claims against the manufacturer.

Question(s) For Expert Witness

  • 1. Please describe your expertise in FDA gCMP and NDA matters.
  • 2. Have you ever served as an expert witness on a case involving allegations pertaining to gCMP and NDA issues?
  • 3. Have you previously audited or consulted pharmaceutical manufacturers on compliance for the above mentioned concerns?

Expert Witness Response E-009785

I have over 25 years of experience in regulatory affairs, drug development, and GMP compliance. My experience was gained in the FDA, pharmaceutical industry, and consulting environments. I have 10 years of experience at the FDA as a researcher, product reviewer, and credentialed inspector. My industry career began at Genzyme Corporation. I’ve held numerous senior and executive positions in regulatory affairs, quality, and biopharmaceutical development at Teva Pharmaceutical Industries, MDS Pharma Services, and Panacea Pharmaceuticals. While in the FDA, I served as a credentialed inspector. I conducted FDA inspections as a product expert along with the FDA District Office. I also conducted solo inspections for product and cGMP compliance. I served as a subject matter expert to FDA Office of Compliance and Office of General Counsel and participated in the issuance of untitled and titled (Warning Letters) letters. In addition, I reviewed responses to enforcement actions and determined suitability and compliance with regulations. I received internal FDA training on laws and regulations governing and interpreting cGMPs. I was responsible for the review of CMC sections of INDs and BLAs and drafted FDA Guidance documents focusing on cGMP and quality. I received numerous awards in the FDA for her work. While in industry, I designed and built GMP Quality Systems, QA and QC groups in companies. My work was both hands-on, such as drafting BPRs and SOPs, and strategic, such as conducting a gap analysis and bringing a quality system into cGMP compliance. My understanding of cGMPs has been validated by these companies successfully passing inspections by the FDA and EMA and receiving GMP compliance certificates through PIC. I have prepared companies for regulatory agency inspections, led companies during these inspections, and prepared acceptable responses to these inspections (issued Form FDA 483s). In my current position as a consultant, I advise clients on FDA compliance matters, conduct cGMP inspections and gap analyses, prepare companies for inspections, and prepare responses to regulatory agency actions. I also draft CMC sections for INDs and NDAs with a strong emphasis on cGMPs. I have served as an expert witness in a similar case. On a regular basis, I audit and consult pharmaceutical manufacturers on manufacturing and quality control deficiencies. I have been deposed 1 time and have been at trial and have testified 1 time. My testimony was on behalf of the plaintiff.

Expert Witness Response E-007290

I’ve previously served as an expert witness on a claim involving very similar issues. I was hired to serve as an expert witness on behalf of a group of shareholders; upon evaluating the materials the company had received from the FDA, along with the information which was subsequently disclosed to relevant parties, I determined that the company had not acted in good faith and was eager to assist the group of shareholders. I’ve also served as an expert witness to explain how FDA information may be interpreted by a pharmaceutical firm (i.e. warning letters) in an instance similar to the case described here. I routinely consult and advise pharmaceuticals on how to properly manage these processes and would be happy to assist on this matter. Please let me know how you wish to proceed.

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