The troubled Indian pharma company received its second FDA warning letter in months, which this time cited quality control and data integrity lapses at its manufacturing facility in Gujarat, India.
Pictured: Sign outside the FDA’s office in Maryland/iStock, hapabapa
The FDA has slapped Intas Pharmaceuticals with another warning letter over manufacturing violations, quality control lapses and compromised data integrity, this time at its plant in Gujarat, India.
The regulator has also put the Indian facility on its import alert list, which allows the FDA’s field operatives to detain products from Intas without physical examination.
In its Nov. 21 warning letter, the FDA pointed to four main issues found at the Gujarat plant over a 12-day site inspection in May 2023. According to the regulator, Intas failed to ensure that the drug products that it manufactures comply with Current Good Manufacturing Practice (CGMP) regulations.
The FDA noted in its letter that “visual inspectors manipulated particle and other defect counts on manual visual inspection records in many instances, in order to keep the finished product batches within rejection limits,” a problem that the regulator said had been going on since 2021.
Intas voluntarily recalled batches of drug products with particle contaminations and has “disqualified” all visual inspectors connected with the data manipulations. However, the FDA in its letter said that the company’s response remains “inadequate,” particularly because it has not comprehensively examined its other CGMP records, nor has it implemented a sweeping and systematic corrective action and preventative action plan.
The regulator also flagged Intas’ failure to “thoroughly investigate” discrepancies in batches or the failure of any of its products to meet specifications, as well as the company’s lack of written procedures and process controls that could help ensure the quality, strength and purity of their products.
This is Intas’ second warning letter from the FDA in recent months. In August 2023, the company received another notice from the regulator, this time for its facility in Sanand, India. The letter flagged several quality control and data integrity issues, including an instance where an analyst destroyed data by pouring acetic acid into a trash bin containing CGMP records.
The same analyst had also reportedly destroyed data sheets, including balance printouts and titration curves. When reported to management, Intas did not immediately launch an investigation, according to the FDA’s letter.
Intas’ Sanand facility was placed on the FDA’s import list on June 1, 2023.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
