Indian API Manufacturer Warned for Serious GMP Violations

The FDA issued Malladi Drugs & Pharmaceuticals a warning letter for significant good manufacturing practice failures at an active pharmaceutical ingredient facility in Tamil Nadu.

In a Sept. 4-8, 2017 inspection, FDA investigators found sections of the facility used in API production were open to the outdoors and observed vermin near open equipment used in manufacturing.

The company committed to correcting the deficiencies in its response to the agency’s initial findings, but the FDA said the response was inadequate because it failed to address the potential risk to product quality and safety.

On Dec. 13, the agency placed Malladi on an import alert for automatic detention of its products at U.S. ports.

The FDA also faulted the firm’s procedures for cleaning vessels used in production. The facility failed to demonstrate that the procedures prevented contamination from foreign matter and impurities and used equipment that was difficult to repeatedly clean. It also kept some vessels filled with water which may have increased the chances of contamination, the agency said.

The agency requested that the facility commit to replacing the unacceptable equipment with ones properly suited for their intended use and called for “a risk assessment for any drugs within their re-test date manufactured using inappropriate equipment and distributed within the United States.”

The facility acknowledged during the inspection that it failed to properly validate an API drug manufacturing process. In addition, it did not have complete control of steps in the process, and over approximately two years, twenty-four batches had out-of-specification test results for an unspecified impurity.

Though the firm responded with data from multiple batches that met specifications, the agency noted the data “is not a replacement for adequate process design, control, CAPA and change management, and does not sufficiently support your claim that your process is robust.”

The agency asked for a comprehensive and independent evaluation of the firm’s CAPA system and an assessment and remediation of its change management system, among other requests.