As China and India continue to manufacture about 80% of all active pharmaceutical ingredients (APIs) for the US market, the US Food and Drug Administration (FDA) is tasked with regulating these ...

Following an inspection earlier this month at Dr. Reddy’s Laboratories’ Medak, India-based site, the US Food and Drug Administration (FDA) sent the firm a Form 483 with five observations, including ...

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to ...

An FDA inspection of a Biocon API plant in Bangalore that concluded last month found a number of issues, including with the plant’s quality-assurance department. But the Indian drugmaker shrugged it ...

Another day brings more bad news for still-closed SanGar Fresh Cut Produce. This time it was the release of the FDA Form 483 report containing observations of the federal food safety inspectors who ...

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Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel. Q. We are a US-based start-up company, and we are ...

The FDA issued a warning letter last year to PharMEDium Healthcare Holdings, the large compounding pharmacy operation that AmerisourceBergen ($ABC) said last week it ...

Our FDA: Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 observations at the conclusion of an inspection. The FDA’s ...

An FDA inspection can be nerve-wracking. Learn what two experts say you can do in person during an inspection to avoid receiving Form 483 observations or a warning letter. Marie Thibault For many ...