Indian drugmaker Theon Pharmaceuticals was issued a warning letter, citing the company for falsifying records and inadequate quality control systems.
The letter, posted on the EudraGMP website, said inspectors found one “critical” deficiency during an inspection conducted by the Maltese National Agency in early March.
The critical issue concerned “evidence of falsification of documents.” Six “major” deficiencies were documented, which included “inadequate pharmaceutical quality system and documentation management, and deficient control of cross-contamination, manufacturing activities, qualification and validation activities and approval of suppliers.”
The facility, which is located in Village Saini Majra, Tehsil Nalagarh, District Solan, Himachal Pradesh, was also cited for 11 other issues. Currently, the plant isn’t producing drugs for the European market, and the agency recommended Theon Pharma not be granted either marketing authorizations or variation applications to current marketing authorizations for the site.
Theon produces both coated and uncoated tablets at the facility, which has a capacity of making about 700 million units a year, according to the company’s website.