Looking to clarify its expectations for manufacturer responses following inspections, the FDA earlier this year unveiled, for the first time, draft guidance on best practices for the industry when ...

The US Food and Drug Administration (FDA) on Friday released a Form 483 issued 18 August to blood testing startup Theranos, citing the company for allowing patients to consent to sample collection in ...

The FDA slammed three Indian drugmakers with Form 483s following recent inspections that uncovered unsanitary conditions, broken equipment and poor recordkeeping. Mumbai-based Alkem Labs was cited ...

In its March 2026 draft guidance, the US Food and Drug Administration (FDA) outlined its current thinking on how drug and certain product manufacturers should approach Form 483 responses to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

A Focus review (thanks to the Freedom of Information Act) of 50 Form 483s issued by the US Food and Drug Administration (FDA) to Indian pharmaceutical and active pharmaceutical ingredient (API) ...

The US Food and Drug Administration (FDA) has issued new draft guidance giving drug manufacturers – for the first time – formal guidance on how the agency expects firms to respond to a Form FDA 483 ...

Recent warning letters have shed light on common mistakes companies make when responding to 483 findings. Here are a few best practices for addressing FDA’s concerns and mitigating the risk of further ...

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Mumbai, Nov. 22 -- The inspection concluded with a Form-483, citing seven observations. Lupin stated that it will address the observations and respond to the FDA within the stipulated timeframe, and ...

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 ...