Intas Pharmaceuticals, based in Gujarat, India, is in the spotlight again as the U.S. Food and Drug Administration (FDA) issues another warning letter, raising concerns about manufacturing violations, lapses in quality control, and compromised data integrity at its Indian facility, as reported in a leading news paper. The FDA has taken further action by placing the facility on its import alert list, giving FDA field operatives the authority to detain Intas products without physical examination.
The warning letter, dated November 21, outlines four significant issues discovered during a 12-day site inspection in May 2023 at the Gujarat plant. The FDA emphasizes that Intas failed to ensure that its manufactured drug products comply with Current Good Manufacturing Practice (CGMP) regulations.
One critical issue highlighted in the letter is the manipulation of particle and defect counts on manual visual inspection records by visual inspectors. This manipulation was reportedly carried out to keep finished product batches within acceptable rejection limits. The FDA notes that this problem has been ongoing since 2021. In response, Intas initiated a voluntary recall of batches with particle contaminations and disqualified all visual inspectors involved in data manipulations. However, the FDA deems the company’s response inadequate, pointing out the lack of comprehensive examination of other CGMP records and the absence of a thorough corrective action and preventative action plan.
The FDA’s scrutiny extends to Intas’ failure to conduct thorough investigations into discrepancies in batches or any failure of products to meet specifications. Additionally, the company is criticized for lacking written procedures and process controls that could ensure the quality, strength, and purity of its products.
This marks the second FDA warning letter for Intas Pharmaceuticals in recent months. In August 2023, the company received a warning for its Sanand facility, citing multiple quality control and data integrity issues. Notably, an analyst at the Sanand facility reportedly destroyed data by pouring acetic acid into a trash bin containing CGMP records. The same analyst was said to have destroyed data sheets, including balance printouts and titration curves. Intas did not promptly launch an investigation, according to the FDA’s letter.
The FDA’s decision to add Intas Pharmaceuticals’ Gujarat plant to the import alert list raises concerns about the quality and compliance status of the company’s products entering the U.S. market. This move grants FDA field operatives the authority to detain Intas products without physical examination, reflecting the severity of the identified manufacturing and quality control issues.
As Intas grapples with regulatory challenges, the company faces a critical juncture in addressing the FDA’s concerns comprehensively and implementing robust measures to ensure compliance with CGMP regulations. The warning letters underscore the importance of stringent quality control, data integrity, and adherence to regulatory standards in the pharmaceutical manufacturing process. The outcome of Intas Pharmaceuticals’ efforts to rectify these issues will significantly impact its standing with regulatory authorities and the pharmaceutical industry’s perception of its commitment to quality and compliance.