During a visit last summer, FDA inspectors flagged eight deficiencies at an Eli Lilly manufacturing plant in Branchburg, N.J., according to an inspection report Reuters obtained through a Freedom of Information Act Request.
The deficiencies were related to problems in "tracking manufacturing process and quality controls, as well as lapses in its calibration of equipment and failure to properly maintain facilities and equipment," Reuters said in a Jan. 18 report. Regulatory experts who spoke to the news outlet said inadequate protection of electronic records regarding the manufacturing process — which poses a risk of data manipulation — and inadequate training for staff who were testing samples of drugs were among the most serious lapses.
The inspection report was redacted to remove the names of affected products, but in a statement to the news outlet, Eli Lilly said, "Importantly, this situation does not affect the quality, safety, or supply of any current or planned Lilly products in the marketplace."
Inspectors' visit to the plant was in response to Eli Lilly requesting "additional flexibility" to manufacture its migraine treatment Emgality on a different production line if needed, the company told Reuters. The visit "resulted in some observations that were, in most cases, either addressed during the inspection or already in progress as program improvements," Eli Lilly said.
Trulicity, a diabetes drug, and cancer treatments Erbitux and Cyramza are manufactured at the plant, though Eli Lilly said none of the products were affected.
The FDA could categorize the lapses as "Official Action Indicated" — the most serious, according to regulatory experts who reviewed the inspection report. The agency declined Reuters' request for comment on the matter.