Roughly a year after receiving an FDA reprimand at its manufacturing plant in Michigan, Indian drugmaker Piramal Pharma has landed in the regulator’s crosshairs once again.
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls related to quality control, written records, equipment maintenance and more.
Regarding the company's quality control unit, the FDA noted that the group's procedures were “not in writing and fully followed.”
At one point, agency inspectors noticed a leak from a piece of equipment that resulted in “liquid being present throughout the floor” in a room at the facility. No operator or supervisor from Piramal was present at the time of the incident, according to the document.
While Piramal’s site head told the inspectors that the operator in charge of the equipment had likely gone to lunch, the FDA found there was “no documentation of the operator activity or his presence within the room.”
Piramal’s issues didn't stop there, with the FDA also noting that the company’s investigations into active pharmaceutical ingredient (API) batch deviations lacked adequate follow-up.
While four manufacturing deviations were reported throughout the course of March 2024, the company failed to produce a documented quality risk assessment to determine the feasibility of further API batches, according to the FDA’s writeup.
Additionally, Piramal’s written records of an investigation into a customer complaint lacked follow-through, the FDA said.
After a customer flagged the presence of foreign particles in a batch of undisclosed API, Piramal used samples from another ingredient batch to test for traces of potential foreign or metallic particles, according to the document.
The problem is, Piramal never documented any effort to retrieve and test the customer's sample in question, according to the FDA. Retention samples from the batch weren’t tested either, the regulator pointed out.
The agency also found Piramal’s equipment maintenance to be subpar, noting that the company’s cleaning procedures for shared equipment used to make API for the U.S. and other global markets had not been validated.
Further, the FDA flagged issues pertaining to Piramal’s material storage. The regulator scolded the company for failing to handle and store components, key starting materials, API containers and closures in the manner necessary to prevent contamination and ensure drugs properly conform to the strength of their active ingredients.
Piramal’s latest FDA reprimand comes after the company disclosed the receipt of a separate Form 483 at its API facility in Riverview, Michigan, last February.
The company noted that the writeup was classified as “voluntary action indicated,” which means the FDA was not ready to take administrative regulatory action but still found objectionable conditions at Piramal’s plant. Piramal said at the time that the observations did not “relate to data integrity,” adding that it was preparing a “detailed response to said observations.”