New Delhi : The US Food and Drug Administration (USFDA) has issued a warning letter to Wockhardt for violating current good manufacturing practice norms at its United Kingdom-based plant.
In the letter addressed to Wockhardt Chairman and Group CEO Habil Khorakiwala, the USFDA said inspectors from October 5 to 9 and October 12 to 13, 2015, had found significant deviations from standard manufacturing practices at the company’s Wrexham-based manufacturing plant, CP Pharmaceuticals.
The significant violations included non-adherence to appropriate written procedures that are designed to prevent microbiological contamination of drug products, the US health regulator said.
Elaborating on the violations at the plant, the USFDA said, “we observed operators touching the external control panel and push carts. Without disinfecting their gloved hands, these operators then opened the Restricted Access Barrier System (RABS) and performed activities”.
Besides, the company failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas, it said.
“Your environmental monitoring program did not sufficiently cover personnel in your ISO-5 area during set-up, filling, and other activities in your aseptic processing rooms,” USFDA said.
“Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a consultant,” it added.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said.
In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at CP Pharmaceuticals into the US, it added.
The FDA issued the letter on November 16, and has given the company 15 days to respond.
In a filing to BSE, Wockhardt said: “Currently, there is no business being conducted from CP Pharmaceuticals to the US market. CP Pharmaceuticals has already initiated required steps to address the concerns raised by USFDA and will be responding to the agency within the prescribed time.