FDA Warns India Facility Over Sterility Failures

FDA sent a warning letter to Vista Pharmaceuticals Limited, dated July 5, 2017, detailing current good manufacturing practice (CGMP) violations found at the company’s Hyderabad, Telangana, India, facility during an inspection conducted from Sept. 19–23, 2016. The violations include failure to appropriately sterilize equipment, failure to establish written process control procedures, and product misbranding.

CGMP violations

According to the agency, inspectors observed equipment in a “state of disrepair” including holes and corrosion in three pieces of equipment. On March 7, 2016, the agency had received a complaint of metal embedded in a tablet produced by the company. The company failed to consider the poor condition of its equipment when it investigated the complaint, according to FDA. “In your response you stated that you have replaced the equipment identified as being in a state of disrepair. However, your response is inadequate because it failed to include a retrospective review of (b)(4)/(b)(4) USP, (b)(4)/(b)(4) mg tablets, and isoxsuprine hydrochloride USP, 20 mg tablets, manufactured for the US market on equipment identified above,” FDA stated in the letter.

The company also failed to establish written procedures and process controls, according to the agency. Investigators found that process validation had not been performed for isoxsuprine hydrochloride USP, 20 mg tablets, yet the company had distributed some batches to the United States from 2014–2016. “In your response, you stated that you were not currently manufacturing isoxsuprine hydrochloride USP, 20 mg tablets and (b)(4). Your response is inadequate. You did not indicate how or when you would complete validation of your manufacturing process for isoxsuprine hydrochloride USP, 20 mg tablets. In addition, you have not conducted a retrospective risk assessment to determine the potential effects of your failure to validate the manufacturing process on the quality of isoxsuprine hydrochloride USP, 20 mg tablets already distributed,” the agency stated.

Misbranding of product

Vista Pharmaceuticals Limited’s isoxsuprine hydrochloride tablets (NDC 61971-065) appear to be identical, related, or similar (IRS) to Vasodilan tablets, according to FDA. Vasodilan tablet are the subject of pending Drug Efficacy Study Implementation (DESI) proceeding 6403, and their approval was withdrawn March 13, 2009. FDA stated in the letter that there is no FDA-approved application for the company’s product on file. The agency says that it is aware of adverse events associated with isoxsuprine hydrochloride and may have to take action if potential safety issues arise.

FDA has also determined that the product is misbranded. “Due to the toxicity and other potential for harmful effect and the collateral measures necessary to its use, isoxsuprine hydrochloride is not safe for use except under the supervision of a licensed practitioner. In addition, this product is intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners … Consequently, the labeling of this drug fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)],” the agency stated.  

Source: FDA