The FDA is taking issue with “the continued uncontrolled use of ‘trial’ injections,” which the agency seeks more clarity on, and which were cited as an issue in warning letters at two other Wockhardt facilities, as well as a recent warning letter for Sun Pharma.
“The procedure does not specify what type of injection should be made as a trial such as whether a standard or sample is to be used for the trial injection. This procedure states that these injections are for informational purposes only. However it does not specify what information the trial injections are to be used to obtain,” the FDA says.
In addition, laboratory records do not include a complete record of all data secured in the course of each test, the agency says, and specifically points out sample injections that were made but where chromatogram data cannot be traced to a documented sample solution prep.
Computer Controls, Sanitary Conditions
The FDA also notes the problem of appropriate computer controls as changes in master production and control records can be made by employees other than authorized personnel.
And the site was notified of not having sanitary conditions. Specifically, the FDA found in its inspections -- which spanned two months from January to March -- that cleaning procedures do not cover all of the areas of the facility.
GMP training was another issue cited by the FDA, which reviewed documents for five employees and found that two did not have documented training in cGMPs (current good manufacturing practices).
The 125,000 square-foot facility operated by Morton Grove was acquired back in 2007 to expand Wockhardt’s product line in the US and has been open since 1995.
Past Troubles
The Form 483 is the latest in a string of issues cited by foreign regulators. Two of the company’s Indian facilities were hit with import alerts last year due to non-compliance.
And the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) withdrew Wockhardt’s GMP certificate at two facilities.