Drugs

Why Are FDA-483 Observations the Same?

Former FDAer Steve Lynn says an analysis of form FDA-483 inspection reports since 2000 shows the leading observations have remained essentially the same. Writing in a Regulatory Compliance Associates online post, Lynn asks how the industry, both the regulators and the regulated, can solve the systemic repeat observations.

Using the FDA interconnected six-system (quality system, production system, packaging and labeling system, laboratory controls system, facilities and equipment system, and materials system) inspection model, Lynn says the total form FDA-483 observations from 2018 to 2021 by category were: Production (27.4%), Quality System (26.2%), Laboratory Controls (19.4%), Facilities and Equipment (16.1%), Materials (6.1%), Data Integrity (3.4%) and Packaging and Labeling (<2%).

“The important takeaway from this article is our collective industry continues to be cited by FDA for the same observations year after year,” Lynn writes. “The same 10 observations pop up again and again going back to 1999, over 23 years. In those 23 years, we’ve seen a rapid increase in knowledge, better equipment, processes, therapies, and technologies, to name a few. It’s definitely been a volatile, uncertain, complex, and ambiguous world we’ve been living in and will continue to be. With all the rapid advancements in processes, products, and services, how are we still seeing the same CGMP observations in our facilities year over year? What can we as an industry do to change these repeat observations?”

Lynn concludes that he does not have an answer to his question. He says his anonymous survey of former FDAers and industry officials known to him produced anecdotal reports that seem to point to a deeper system issue, at the line level, within the quality units, laboratories, operations, and the top management.

“I do not think one person, one firm, one trade organization, or one consultancy has the solution,” he writes. “It could be argued that the solution lies in our collective knowledge and experience.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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