US-FDA inspection at Strides Pharma Inc USA facility ends with 4 procedural observations
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US-FDA completed a routine cGMP inspection at Strides Pharma Inc's formulations facility in Chestnut Ridge, New York from December 17 to 23, 2025. At the end, FDA issued a Form 483 with 4 observations, which the company says are procedural in nature with no expected impact on supply of commercial products. SPI will respond to FDA within the stipulated time and is confident of addressing all observations.
Minor procedural observations, no supply disruption expected. Company confident of resolving them with FDA.