FDA Warns Mylan’s Indian API Facility Over Contamination Concerns

Regulatory NewsRegulatory News | 12 November 2019 |  By 

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent last week to Mylan’s active pharmaceutical ingredient (API) manufacturing site in Andhra Pradesh, India, highlighting “contamination at levels above the limit” for some API batches.

FDA’s inspection of the site in May and June uncovered, “Multiple contract manufacturers supplied solvents that were contaminated with [redacted], but your firm lacked documentation of which tanks were used to store these solvents,” the letter says. “Although you acknowledged that there was no record of usage for each of the recovered solvent tanks, your response did not provide sufficient information on attempts to retrospectively reconcile the number, identification, and usage of the tanks.”

FDA also raised questions about the site’s ability to clean equipment to prevent contamination or carry-over material that would alter the quality of the API.

There is no assurance that your cleaning methods are adequate to clean and prevent contamination or carry-over of drugs manufactured on non-dedicated equipment,” the agency says.

Some areas were labeled as clean, but FDA investigators found stains that were later determined to be residual API.

FDA recommends a “comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards” and that the Mylan site engage with a consultant on CGMP deficiencies, among other recommendations.

Cadila Healthcare Limited

FDA on Tuesday also released a warning letter with repeat violations at Cadila’s drug manufacturing facility in Ahmedabad, India following an inspection in April and May.

Similar to Mylan, FDA raises contamination concerns with the Cadila site.

“Significant equipment flaws and cleaning deficiencies resulted in cross-contamination between your drug products,” the letter says. “After our inspection, your firm also tested reserve samples of selected batches to assess the potential for cross contamination. Your testing confirmed the presence of active ingredients manufactured in numerous samples tested.”

FDA also notes that the site failed to explain when the cross-contamination involving numerous products started and why it had not been detected. “The extent of the cross-contamination found suggests a lack of assurance that products meet appropriate standards for identity, quality, purity and safety,” the letter says.

Last month, Cadila informed FDA that it would permanently cease production of injectable drug products for the US.

Mylan Laboratories Limited - Unit 8

Cadila Healthcare Limited 


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