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# FDA Flags Sterility, Contamination Control Issues at India Plant
- URL: https://www.fdaweb.com/fda-flags-sterility-contamination-control-issues-at-india-plant/
- Published: 2026-03-16T12:00:00.000Z
- Updated: 2026-09-14T13:35:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160821

FDA inspectors have cited multiple manufacturing and quality control deficiencies at a sterile drug production facility operated by Gland Chemicals Private Limited in Chennai, India, according to an inspection report issued to the company.

The observations were documented in a [Form 483](https://www.fda.gov/media/191557/download?ref=fdaweb.com) issued following an FDA inspection conducted from in November at the company’s site in the SIPCOT Industrial Park in Tamil Nadu. The facility manufactures sterile drug products for the U.S. market.

In the report, FDA investigators said the company failed to establish adequate controls to prevent contamination and mix-ups during manufacturing and laboratory operations. Inspectors cited deficiencies in how samples were transferred and handled between production areas and quality control laboratories, including the use of non-dedicated equipment and common storage areas for different types of samples awaiting analysis.

The agency also raised concerns about the company’s environmental monitoring and sampling practices, stating that sampling locations were selected randomly rather than based on a scientifically justified assessment of areas with the highest contamination risk.

Additional observations focused on the firm’s aseptic processing operations. According to FDA, procedures intended to prevent microbiological contamination of sterile products lacked sufficient validation, including shortcomings in aseptic process simulation, commonly known as media fill studies. Inspectors noted that rejected vials during filling and stoppering operations did not always have documented root causes.

FDA also said the company’s quality unit failed to conduct a comprehensive risk assessment of aseptic processing interventions that occur during sterile filling operations. Without such assessments, investigators wrote, the firm lacked a sound scientific basis for determining how operator interventions might affect sterility assurance and environmental monitoring requirements.