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FDA Warns Antihistamine API Manufacturer in India

Posted 28 March 2018 | By Zachary Brennan 

FDA Warns Antihistamine API Manufacturer in India

The US Food and Drug Administration (FDA) earlier this month sent a warning letter to India-based active pharmaceutical ingredient (API) manufacturer Keshava Organics for repeat CGMP deficiencies, including not properly investigating out-of-specification (OOS) results, among other violations.

FDA notes that the company’s retrospective review of OOS results “shows a pattern of recurring, similar OOS results for which investigations were insufficient, including a lack of corrective actions and preventive actions (CAPA).”

The firm investigated “numerous OOS results between February 2015 and April 2017 as ‘incidents’ and not as OOS results,” the agency said, following its inspection from 25 May to 31 May 2017.

Keshava also failed to maintain complete data for APIs tested and distributed to the US.

“For example, we found test data sheets with missing sample weights for identity testing, batch/lot numbers for reference standards and reagents, equipment identification, and complete thin layer chromatography data for related compounds,” FDA said.

According to the company’s website, the firm’s manufacturing facility about 100 kilometers north of Mumbai received FDA approval to manufacture select antihistamine APIs in 2011.

Keshava Organics Pvt. Ltd. 3/15/18

Categories: Regulatory News

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