Gland Pharma Limited has announced the successful conclusion of a routine Good Manufacturing Practice (GMP) inspection conducted by the United States Food and Drug Administration (USFDA) at its facilities in Visakhapatnam.
The inspection was carried out at the company’s VSEZ Sterile Oncology Formulations Facility and API Facility in Visakhapatnam. The regulatory inspection commenced on August 24, 2026, and concluded on September 1, 2026.
According to the company’s regulatory disclosure, the USFDA inspection concluded with zero (0) Form 483 observations. A Form 483 is issued by the USFDA when investigators identify conditions that may constitute violations of regulatory requirements.
The absence of Form 483 observations indicates that no observations were issued by the USFDA investigators at the conclusion of this inspection. The outcome is relevant to the company's manufacturing operations supplying pharmaceutical products and active pharmaceutical ingredients to regulated markets.
