Sun Pharmaceutical Industries Receives 8-Item 483
June 16th, 2025 // 1:34 pm @ jmpickett
Sun Pharmaceutical Industries Limited received an eight-item 483 after a June 2 to 13, 2025 cGMP inspection. The inspection was conducted at the firm’s Halol facility in Gujarat, India. The Halol facility is one of Sun Pharma’s largest facilities and has had regulatory issues before. The last inspection was in May 2022 and it is still under an import alert after getting an FDA warning letter.
Limited information is available about the latest 483. It is believed there were possible procedural and documentation lapses that require correction actions.
