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USFDA says team ‘threatened’ during Wockhardt inspection

May 28 2014, 12:37 IST
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The problems encountered by the investigators started after the document was provided to person in charge of the facility. The problems encountered by the investigators started after the document was provided to person in charge of the facility.
SummaryThe problems encountered by the investigators started after the document was provided to person in charge of the facility.

Wockhardt’s vice-president in charge of manufacturing, Arvindkumar J Thakkar, threatened investigators during an inspection of the company’s Waluj plant in late March last year, documents sourced from the US Food and Drug Administration (FDA) indicate.

An Establishment Inspection Report (EIR) dated November 12, 2013, sourced by FE under the US Freedom of Information Act says, “Due to persistent non-cooperativeness encountered during this inspection despite repeated verbal warnings provided to the management, an accurate assessment of the firm’s overall Quality System could not be completed.”

It further notes, “Despite daily warnings provided to the management, we continued to encounter repeated instances where employees provided false and misleading information.”

“At the close of the inspection on 03/22/13, Mr Arvinkumar J Thakkar, VP Manufacturing, requested the removal of Observation 1 and appeared to be threatening investigators. The inspection was immediately closed, and all exhibits were hand-carried from the site in a hired taxi,” the report, which was issued more than seven months after the inspection, said.

Thakkar, a LinkedIn profile says, was Wockhardt’s vice-president of operations till January 2014, having worked with the drug firm for about four years. Since February 2014, he has been working as senior vice-president with Cadila Pharmaceuticals.

The inspection of the company’s Waluj facility located in Aurangabad in Maharashtra was conducted between March 18 and March 22, 2013. Following the inspection, the investigators raised a a document — Form 483 — listing the deficiencies noted during the inspection. The problems encountered by the investigators started after the document was provided to person in charge of the facility.

Observation 1 according to Form 483, also sourced by FE under the FOIA, says that during the inspection of the sterile manufacturing units on March 18, visual inspection of in-process injectable products showed presence of “black particles, fibers, missing glass ball”. The report has been signed by USFDA investigators Peter Baker and Parul Patel.

“On 03/20/13, investigators were served unsealed water bottles, and each investigator developed stomach problems during the course of the inspection. Due to the threatening behavior and personal safety concerns encountered during this inspection, it is suggested that an inspectional team perform the follow-up inspection with a clear emergency plan in place prior to arrival,” the USFDA investigators noted.

A detailed email sent to Wockhardt seeking comments on the observations noted in the EIR did not elicit any response.

The records also show that Wockhardt’s

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