The U.S. FDA inspected Unit-IV of APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations.
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The U.S.Food and Drug Administration has issued five observations to Aurobindo Pharma subsidiary APL Healthcare’s unit in Andhra Pradesh.
The U.S.FDA inspected Unit-IV of APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations. Aurobindo Pharma said the observations are procedural in nature and “we will respond to the U.S.FDA within the stipulated timelines.”
The company is committed to maintaining the highest quality manufacturing standards at all its facilities worldwide, it said following the development, which comes close on the heels of the three observations U.S. FDA issued to the active pharmaceutical ingredients (API) manufacturing facility of another subsidiary, Apitoria Pharma, in Hyderabad.
Published – December 19, 2025 09:43 am IST
