56 pages • 1 hour read
Katherine EbanA modern alternative to SparkNotes and CliffsNotes, SuperSummary offers high-quality Study Guides with detailed chapter summaries and analysis of major themes, characters, and more.
Peter Baker is a drug investigator for the FDA, an organization tasked with ensuring the safety and efficacy of medications. Eban describes a visit Baker conducted on March 18, 2013. Over five days, he inspected a plant in India run by the generic drug company Wockhardt Ltd.
Eban describes how manufacturing irregularities and quality control issues at pharmaceutical plants can have serious implications for patient safety. At the same time, failed inspections can cost drug companies millions of dollars in lost revenue and can damage their reputation.
Wockhardt, like other overseas drug companies, has an advantage. While FDA investigators arrive at US-based plants unannounced and stay for however long is necessary, overseas plants are typically given advance notice of inspections, due to the complicated logistics involved with traveling and obtaining visas. Wockhardt knew ahead of time that Baker was coming, and he only had five days to inspect an enormous site.
Company officials prepared for the visit accordingly: They instructed employees to clean and organize the plant, remove any evidence of manufacturing irregularities, and present a facade of compliance. This approach usually worked. During a previous inspection, Wockhardt was given a passing grade, even though inspectors found evidence of manufacturing violations.
Business & Economics
View Collection
Challenging Authority
View Collection
Globalization
View Collection
Health & Medicine
View Collection
Journalism Reads
View Collection
New York Times Best Sellers
View Collection
Politics & Government
View Collection
Power
View Collection
Science & Nature
View Collection
The Best of "Best Book" Lists
View Collection
Truth & Lies
View Collection