SMS Pharmaceuticals Limited has successfully completed its second United States Food and Drug Administration (USFDA) inspection at its Central Laboratory Analytical Services facility in Hyderabad, Telangana, with zero regulatory observations recorded.
The inspection, conducted from June 23 to June 25, 2025, at the facility located in Gagillapur Village, Medchal Malkajgiri District, concluded without any Form 483 observations being issued by FDA investigators.
Regulatory Significance
An FDA Form 483 is typically issued to company management at the conclusion of an inspection when investigators observe conditions that may constitute violations of the Food Drug and Cosmetic Act and related regulations. The absence of any Form 483 observations indicates that SMS Pharmaceuticals' analytical laboratory met all FDA compliance requirements during the inspection.
Company Commitment to Quality Standards
In a BSE filing, SMS Pharmaceuticals stated that "the Company is committed to meeting the highest quality standards and is further committed to full compliance with CGMP & GLP regulations at all our manufacturing & Analytical facilities."
The Central Laboratory Analytical Services operates as the company's independent testing laboratory, providing analytical services that support the pharmaceutical manufacturing process. This marks the second successful USFDA inspection for this particular facility, demonstrating consistent regulatory compliance over time.
Facility Operations
The Telangana-based analytical laboratory serves as a critical component of SMS Pharmaceuticals' quality assurance infrastructure, supporting the company's commitment to maintaining current Good Manufacturing Practice (CGMP) and Good Laboratory Practice (GLP) standards across its operations.
