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Regulatory Focus™ > News Articles > 5 > FDA Warns Indian, US Drugmakers for GMP Violations

FDA Warns Indian, US Drugmakers for GMP Violations

Posted 15 May 2018 | By Michael Mezher 

FDA Warns Indian, US Drugmakers for GMP Violations

The US Food and Drug Administration (FDA) has warned Indian active pharmaceutical ingredient (API) maker Reine Lifescience and North Carolina-based contract manufacturing organization (CMO) Ei LLC for good manufacturing practice (GMP) violations.

Reine Lifescience

FDA issued a warning letter to Reine Lifescience after inspecting the company’s Gujarat, India facility in October and November 2017.

FDA says during the inspection its investigator found analytical data in a folder normally used for product development that contained batch data for API that “appeared to differ significantly from recorded test results.”

FDA also says that the audit trail feature was disabled on instruments used for quality control testing, including the company’s high-performance liquid chromatography system, and that analytical systems at the facility lacked controls to prevent staff from deleting or changing electronic data.

Additionally, FDA says the company released and shipped API intended for the US market that were manufactured using the same equipment used to make other products, without validating their equipment cleaning processes.

As a result of these issues, FDA has recommended Reine hire a GMP consultant to help it address the deviations identified during the inspection and is requesting that the company conduct an investigation into its data integrity issues.


FDA’s warning letter to Ei LLC comes after the agency inspected the company’s Kannapolis, North Carolina facility in October 2017.

According to FDA, the company manufactured topical drugs and pesticides using the same equipment in the same building.

“It is unacceptable as a matter of cGMP to continue manufacturing drugs using the same equipment that you use to manufacture pesticides or other non-pharmaceutical products due to the risk of cross-contamination,” FDA writes.

FDA also cites the company not adequately validating its cleaning procedures to ensure against cross contamination between different drugs manufactured using the same equipment.

Finally, FDA says Ei failed to thoroughly investigate unexpected discrepancies in certain batches of its products, including out-of-specification results for batches of products that were produced using the same equipment as it used to make pesticides and for other commercial manufacturing.

Warning Letters: Reine Lifescience, Ei LLC

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