Wockhardt’s India Plant Hit With Form 483 Over GMP Violations

An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings.

FDA inspectors uncovered nine GMP violations at the company’s sterile and non-sterile manufacturing facility in Shendra Aurangabad, according to a Form 483 issued after a January inspection. At the time, Wockhardt CEO Habil Khorakiwala characterized the issues as “minor,” saying more than half of them could be resolved within a few weeks.

Findings from the 483 point to more substantive problems, including missing GMP records, untrained personnel and rejected API batches stored alongside approved ones.

The document contends that 935 GMP files had been deleted from the plant’s servers prior to the inspection. FDA inspectors further concluded that the company neglected to report 22 failed results from a system whose function was redacted from the document, and the administrative password granting access to GMP data was shared by multiple production and engineering personnel.

FDA inspectors also found fault with the company’s handling of hard-copy reports as well, noting that they found “a bag of unaccounted [for] shredded documents” that included quality control and lab test results. Additionally, the agency claims that three test printouts were found in the trash, two of which contained unreported failed analyses.

Environmental monitoring trend reports did not seem to fare much better, with the 483 stating that some had gone missing while another report appears to have been conducted late.

The facility also seems to have problems with sterility issues, as FDA inspectors reported an employee working in an aseptic area while not adequately covered. In another instance, a sterile gown was seen with repairs and no unique identifying marks.

Another concern was the company’s handling of complaints. The 483 referenced 11 complaints for missing primary labels for finished product containers, but the company neglected to conduct a follow-up investigation.

The inspectors also allege that a rejected API batch was found in the approved materials storage area, even though Wockhardt procedures require that they be stored in a separate area under lock and key.

Lastly, the document contends that employees visually inspecting finished product vials were unqualified for the task and that the company lacked a qualification program for a related function.

Similar issues last year led the company to pull more than 162,000 cartons of blood pressure and ulcer drugs off store shelves, after the FDA accused it of not adequately investigating customer complaints.

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