US FDA inspection at Caplin Steriles unit ends with 10 procedural observations
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US FDA conducted an unannounced inspection at Caplin Steriles' injectable and ophthalmic facility in Gummidipoondi from August 13 to 21, 2026. The facility received Form 483 with 10 observations, all procedural in nature, with no data integrity issues and no repeat observations. The company is addressing the observations and will respond to US FDA within the stipulated timeframe.
Minor procedural observations, no data integrity issues. Limited near-term impact; company response to US FDA is pending.