Two More Indian API Companies Earn FDA Warning Letters

Two More Indian API Companies Earn FDA Warning Letters

August 29th, 2013 // 2:03 pm @

Latest FDA and cGMP Compliance News

Two Indian drug companies – Promed Exports and Posh Chemicals – are the latest firms in that country to receive serious FDA warning letters.

Promed is a drug maker, and Posh is a manufacturer of APIs. Both companies were sent warning letters citing them for cGMP regulation violations and allegations of fixing data.

The warning letter to the Promed facility noted that FDA was concerned that its environmental monitoring system does not ensure the environment is adequate for the proper aseptic processing of sterile products.

Also, Promed was still manufacturing batches without explaining what had caused a clogging that happened in the product transfer process in March 2012.

In the Posh warning letter, the firm was cited for problems with test procedures and the recording of data. Some of these violations included 21 CFR Part 11 violations, such as the failure to protect computer data from unauthorized access, and also for failure to follow and document several quality related activities.

During the audit in March, FDA noted that a Posh QC chemist stated that under the direction of a supervisor, he had noted false visual exam data into the log book for reserve samples.

These two warning letters are only the latest that have been sent to various Indian manufacturing plants for cGMP violations this summer.

Strides Arcolabs got a 483 this moth, and Fresenius Kabi and Wockhardt both got warning letters in July.

Fresenius fired all of the management at that plant that was involved with serious QC data cover ups that were noted in the letter. Wockhardt’s share price plunged 10% when the warning letter was published. That firm also had an import alert in the US in May.

India has become very aware of the cGMP problems with FDA. The Central Drug Standard Control Organization in India sent a letter to all of its drug companies this summer, warning them to a lot of FDA scrutiny of their operations and concerns about quality in foreign markets.

It noted that India imports drugs to 200 countries, and recently FDA and other Western regulatory bodies have noted serious cGMP regulation violations with some products coming from Indian drug companies.

It remains to be seen if these Indian companies will clean up their act, but it is certain that FDA is looking closely at the GMP quality of products coming in from India.


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