US FDA import alert and warning for Indian API maker

By Flora Southey

- Last updated on GMT

The US FDA has cited cleaning validation and electronic data access concerns in its warning letter to Indian API maker Reine Lifesciences.

The US Food and Drug Administration (FDA) issued the warning letter​ following an inspection at Reine Lifescience’s manufacturing facility in Gujurat, India.

The active pharmaceutical ingredient (API) maker has been on US Import Alert 66-40​ since March.

Good manufacturing practice (GMP) violations cited include failing to provide analytical method documentation and inadequate data system controls.

According to the letter, an FDA investigator observed analytical data in a folder titled ‘PD Trial’: “While the folder was normally intended for product development, the folder contained batch data for API, and results appeared to differ significantly from recorded test results.”

In addition, the investigator observed that the firm’s quality assurance executive – who also performed analytical testing – had administrator access to each electronic data system.

Reine Lifescience’s cleaning validation procedures were also flagged during the visit: “You released and shipped API to the US market that were manufactured using multi-product equipment before completing equipment cleaning validation.”

The cleaning validation reported provided – completed once the APIs had been shipped to the US – also lacked evaluation of cleaning methods for the product “identified as worst case.”

The FDA has recommended Reine Lifesciences hire a consultant to amend GMP deviations.

Reine Lifescience did not reply to a request for comment.

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