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The US FDA issued Form 483 with eight observations following a GMP inspection at Sun Pharmaceutical’s Halol unit, which concluded on June 13, 2025. The facility remains under import alert. Sun Pharmaceutical Industries share price closed at Rs.1,688.70.
The US Food and Drug Administration (FDA) has issued a Form 483 with eight observations to Sun Pharmaceutical Industries Ltd following a recent inspection at its Halol manufacturing plant in Gujarat. The Good Manufacturing Practices (GMP) inspection was carried out between June 2 and June 13, 2025.
This development adds to the regulatory pressure on one of Sun Pharma’s largest manufacturing units, which is already under an import alert. The Halol facility was previously inspected in May 2022 and had received a warning letter from the US FDA following compliance concerns.
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US FDA conducted a GMP inspection at the Halol plant from June 2 to 13
Form 483 with eight observations was issued at the end of the audit
The Halol facility remains under an existing import alert
Last US FDA inspection occurred in May 2022
Surprise audit first reported by media on June 3, 2025
Sun Pharmaceutical Industries share price closed at Rs.1,688.70 on Friday
Also read: US FDA issues VAI classification with no observations for Syngene plant
The issuance of Form 483 implies that the FDA has identified conditions at the plant that may need corrective action. While not a final determination of non-compliance, such findings require prompt responses and remediation by the company to avoid escalation to further regulatory action.
Item | Details |
Facility Inspected | Halol manufacturing unit, Gujarat |
Inspection Dates | June 2 to June 13, 2025 |
FDA Observations | Eight (Form 483 issued) |
Import Alert Status | Ongoing (since prior inspection) |
Last Inspection Before 2025 | May 2022 |
Sun Pharmaceutical Industries share price | Rs.1,688.70 (as of June 13, 2025) |
The Halol unit plays a crucial role in Sun Pharma’s supply chain for regulated markets, particularly the United States. Given the existing import restrictions, further FDA scrutiny increases compliance risks and may delay product approvals or exports from this site.
Although the company has not provided specifics on the eight observations, the Form 483 typically outlines issues related to manufacturing controls, quality assurance, or documentation practices. The company is expected to respond with a corrective action plan within the required regulatory timeline.
Sun Pharmaceutical Industries share price may reflect cautious investor sentiment in the coming sessions as the market digests the implications of the latest regulatory development.
Also read: City Union Bank confident of FY26 margins despite RBI rate cuts
Source: CNBCTV18
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