US FDA says Srikem plan will not fix data integrity issues at Taloja plant

By Gareth Macdonald

- Last updated on GMT

iStock/PhotoBylove
iStock/PhotoBylove

Related tags Data integrity Food and drug administration

The US FDA still has doubts about Srikem Laboratories’ plan to fix data integrity problems at its API manufacturing facility Taloja, India.

The US agency detailed its criticism of Srikem’s remediation proposals in a letter​ published on Tuesday, explaining that measures proposed do not adequately address problems identified by inspectors who visited the site last December.

Foremost among the concerns is that the measures put forward by Srikem will not prevent a number of data integrity issues.

The Food and Drug Administration (FDA) explained that although Srikem’s response includes records missing at the time of the inspection, it does not show how the firm will “retain complete and accurate records of all tests​.”

The agency suggested Srikem hire a consultant – a standard recommendation when any firm fails an inspection – and called on it to fully investigate its data for inaccuracies, interview current and former employees and put together a detailed corrective action plan.

Srikem is currently banned from shipping drug ingredients to the US under an import alert imposed in July​.

The firm's website stated that the “Taloja Plant is inspected and accepted by USFDA​” at the time of publication.

Srikem did not respond to a request for comment.

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