Compliance review: Sun Pharma’s Halol plant gets 8 USFDA observations; company vows remedial steps after inspection

Sun Pharmaceutical Industries faces scrutiny. The USFDA issued a Form 483. This follows an inspection of its Halol manufacturing plant in Gujarat. The inspection occurred between June 2 and June 13, 2025. Eight observations were noted regarding Good Manufacturing Practices. Sun Pharma is expected to respond. They will submit a remediation plan to address the concerns.

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