The QMN Weekly Bulletin

FDA Warns API Maker Sal Pharma Over GMPs Following Import Alert

May 12, 2017

The FDA issued a warning letter to an API manufacturing facility in Hyderabad, India, citing adulteration, misbranding and other issues.

The agency labeled the Sal Pharma facility’s APIs as adulterated because of inadequate manufacturing, processing and packing controls, following an inspection in late June 2016. The agency placed the firm on an import alert Feb. 15.

The FDA investigators observed failures to transfer quality or regulatory information to customers, as well as problems with relabeling and holding of APIs.

The company omitted the names and addresses of the original manufacturers of the API on certificates of analysis sent to customers, according to the warning letter dated April 20, and generated COAs by replacing the original manufacturers’ information with its own letterhead, the agency said.

Additionally, two of the company’s suppliers were not registered with the FDA as drug manufacturers. Sal Pharma shipped APIs from these firms to the U.S., declaring on importation documents that it was the manufacturer.

The FDA warned the company to set up an effective quality system, including written procedures for cGMPs, and to maintain adequate storage conditions — and said it may continue to refuse entry of product to the U.S. until the company complies.  

Few things in drugmaking are as challenging as process validation — nor as likely to trip you up with FDA inspectors. Hundreds of individual manufacturing processes to validate. And the most common mistakes occur after the work of validation has taken place: when documenting the work to show that it's been done. Order Managing Process Validation: A Drugmaker's Guide and gain the confidence to conduct process validations that reduce risk and satisfy regulators.

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