FDA Warns Wockhardt Subsidiary Over Aseptic Production Issues
The US Food and Drug Administration (FDA) sent a warning letter to Wockhardt Limited founder Habil Khorakiwala last week over good manufacturing practice (GMP) violations at the company's CP Pharmaceuticals subsidiary in Wrexham, UK.
Over the course of a seven-day inspection in October 2015, FDA says its investigator found the company failed to follow its own procedures intended to ensure product sterility. Additionally, the agency says the company's environmental monitoring program and disinfection practices were inadequate for aseptic processing.
This is not the first time FDA warned the facility over aseptic processing issues. In 2010, the agency sent a warning letter to CP Pharmaceuticals citing several issues with its systems for preventing contamination.
"Your aseptic processing control systems and operations do not provide assurance that the production rooms and equipment maintain aseptic conditions. Additionally, your environmental monitoring practices do not include adequate routine examination of the facilities and equipment to ensure that possible contaminants can be detected," FDA wrote in 2010.
The warning letter adds to concerns over GMP compliance by Wockhardt. In August, FDA added the company's Ankleshwar, India site to the Import Alert list alongside two other Wockhardt facilities.
Details
In the new warning letter, FDA lists four separate instances where the company failed to follow written procedures to prevent microbial contamination of its products. In one instance, FDA says "multiple operators who had touched surfaces and items in the ISO-7 clean area failed to disinfect their hands before performing activities within the ISO-5 area."
Furthermore, FDA says the company's quality unit failed to document or capture any of the four deviations when it reviewed videos of the operation.
"The ISO 5 is a critical area because sterile product is exposed and therefore vulnerable to contamination. Your aseptic filing process should be designed, and operations executed, to prevent contamination hazards to your sterile product," FDA writes.
Due to the repeat nature of some of the issues, FDA says it recommends the company hire a consultant to help it meet GMP requirements for aseptic processing.
Going forward, FDA says CP Pharmaceuticals must conduct "a comprehensive evaluation of the design, control, maintenance, and oversight of [its] aseptic processing lines," as well as a risk assessment to determine the potential impact of the violations cited in the letter on the company's drug products.
Lastly, FDA says the company must develop an "overall management strategy that describes how [its] executive management will oversee improvements in operation and ensure ongoing oversight to provide for sustainable quality assurance."