AstraZeneca Pharmaceuticals, LP – FDA EIR, Jan 30, 2018

An FDA inspection of AstraZeneca Pharmaceuticals, LP in Gaithersburg, MD, took place from January 25 to January 30, 2018. This routine surveillance inspection focused on Postmarketing Adverse Drug Experience (PADE) reporting, in accordance with Compliance Program Guidance Manual 7353.001 and regulatory requirements for timely safety reporting (21 CFR 314.80(c)(1)(i)). The inspection reviewed reporting for products such as Synagis, Zomig, Fasenra, and Tagrisso.

The main violation identified was the failure to report all serious and unexpected adverse drug experiences to the FDA within the mandated 15 calendar days. Specifically, approximately 199 late reports were observed for Synagis, with some delays exceeding 3,000 days, attributed to a non-US marketing authorization holder. Fourteen late reports for Zomig were noted, some delayed by over 1,000 days, due to internal human error with a licensing partner. Additionally, nine late reports were found for Tagrisso.

Following these findings, an FDA-483 "Inspectional Observations" was issued to the Vice President of Patient Safety Oncology. AstraZeneca management committed to providing a written response within 15 business days. They indicated that corrective actions were implemented for Synagis and Zomig's identified issues, and a root cause analysis would be conducted for Tagrisso's late submissions. Management affirmed the company's dedication to maintaining timely adverse drug experience reporting and regulatory compliance.