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 problems did not begin in May 2013, which is when the Waluj unit received an import alert. The EIR, which is a summary of findings over several previous inspections, says an audit was conducted in January 2012 after which an 11-item Form 483 was issued.
“Due to time constraints, uncooperative behavior of management, and significant delays in providing cGMP (current good manufacturing practices) related documentation during the course of this current inspection, the corrective actions taken in response to the previous FDA 483 could not be fully evaluated,” the EIR states.
After the issuance of Form 483 in March 22 for the Waluj facility, the USFDA issued an import alert on the facility on May 22, 2013, which prevented products manufactured in the plant from entering the US.
The regulator then escalated the issue by raising a warning letter dated July 18 on the facility after Wockhardt did not provide satisfactory responses for the steps taken to rectify the violations observed in USFDA-mandated (cGMP).