Following a slowdown in FDA inspections in recent years due to the pandemic, inspections are now back in full swing, and two Indian pharmaceutical companies have recently faced scrutiny from the agency.
The FDA has issued three Form 483s after conducting inspections of three drug manufacturing plants in India. July 7 Intas Pharmaceuticals received one write-up, while the other two were given to Ipca Laboratories.
Intas Pharmaceuticals, located in Ahmedabad, Gujarat, India, received a significant number of observations from the FDA following an inspection of its manufacturing facility from May 1 to May 12. The FDA cited 16 observations, highlighting concerns such as incomplete batch production and control records, unresolved production discrepancies, inadequate written procedures, insufficient measures to prevent microbial contamination, subpar cleaning practices, poor environmental control, inadequate computer oversight, missed equipment checks, and lapses in quality control. The FDA also noted that Intas had difficulties ensuring appropriate computer system security to restrict access to authorized personnel only.
On Intas’ batch production and control records, the FDA noted that “visual inspection data for finished parenteral drug products appeared to be routinely manipulated by your manual visual inspectors to stay just below the established reject particle limits.”
To make matters worse, the FDA observed a “pattern of visual inspection records being altered to change the reported counts from values that exceed the individual particle limits.”
Ipca Laboratories faced criticism for lapses at its facilities in Ratlam and Dhar, Madhya Pradesh, India. The FDA conducted inspections at these locations from June 5 to June 13 and from June 15 to June 23, respectively. The inspection at the active pharmaceutical ingredients (API) facility resulted in 10 observations, including issues with batch failure investigations, release of failed drug ingredients, inadequate testing procedures, inconsistent production, insufficient quality control, and reporting oversights. The inspection at the pharmaceutical manufacturing plant led to 8 observations related to similar problems with batch discrepancies, undefined time limits, unverified stability testing, and poorly maintained equipment.
Indian pharmaceutical companies have increasingly become targets of FDA inspections in recent months. Sun Pharma, Centrient, Cipla, Amneal, and Dr. Reddy’s are among the companies that have faced regulatory scrutiny. In December, the FDA issued an import alert on one of Sun Pharma’s manufacturing facilities in India, impacting shipments to the US market. Centrient received a regulatory write-up at its production plant in Punjab, India, in the same month.
Cipla faced severe criticism in a report on its Pithampur facility, which highlighted testing and record-keeping issues, as well as mishandling of customer complaints. Amneal Pharmaceuticals’ India injectables plant also faced FDA inspection findings that revealed sanitation problems and employees working without proper eyewear. The agency also discovered a “mold-like” substance in certain areas of the facility.
