Intas Pharmacuticals has received another warning letter from the U.S. FDA regarding its plant in Gujarat, India. The warning letter posted November 28 names four issues found at the plant following a 12-day site inspection in May 2023. According to the FDA, the company failed to ensure drug products manufactured at the site comply with current Good Manufacturing Practice (cGMP) regulations.
 
The letter cites manufacturing violations, quality control issues, and compromised data integrity. This includes manipulated manual visual inspection records. While Intas recalled batches of drug products with particle contaminations, the FDA claims the response remains inadequate. The FDA claims the company has not thoroughly examined its other cGMP records and has not implemented a systematic corrective action and preventative action (CAPA) plan.
 
Additionally, the FDA cites failure to investigate discrepancies in batches or the failure of any of its products to meet specifications, as well as a lack of written procedures and process controls, which are used to help ensure quality, strength, and purity of products.
 
Intas Pharmacuticals’ plant in Gujarat, halted operations in December 2022 following a failed inspection by the FDA citing 11 violations, including quality control. 
 
The Gujarat facility remains on an import alert list, which allows the FDA to detain products from Intas without physical examination.
 
In August 2023, Intas received a notice from the FDA regarding its Sanand facility in India. The letter cited several quality control and data integrity issues, including the destruction of data containing cGMP records.