In a scathing rebuke, the United States Food and Drug Administration (USFDA) has taken Indian drugmaker Dr. Reddy's to task for a slew of maintenance shortfalls, as revealed in the recent Form 483 filings, issued to a company at the end of an inspection if investigators observe conditions that, in their assessment, could be considered violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The regulatory body's inspection of Dr. Reddy's production plant in Telangana in late October has exposed a series of critical violations that jeopardise the safety and quality of drug products.
Post-inspection, the USFDA and the FDA pointed out the 10-observation write-up and rebuked Dr. Reddy's for neglecting essential building and equipment maintenance.
Shockingly, investigators found that workers failed to regularly clean equipment and utensils, posing a serious risk of contamination that could compromise the integrity of drug products manufactured at the facility.
In their first observation, the investigators reported, “Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality, or purity of the drug product.
“Specifically, major production equipment used to manufacture (....) dosage drug products is not appropriately cleaned and maintained to prevent contamination,” they observed.
Further intensifying the censure, the FDA highlighted that certain equipment crucial for commercial release and stability analysis did not meet calibration specifications. The revelation that Dr. Reddy's has filed 40 incident reports related to lab equipment failing routine calibration over the last three years raises serious questions about the company's commitment to maintaining quality standards.
The investigators further wrote, “We investigated On October 19, 2023, we observed the firm's production operators and IPQA officers conducting inadequate visual inspection of (...) upon major cleaning (it contained residues of previously manufactured products on (...) and (....) product contact areas). As a result of this, residues of previously manufactured drug products were observed inside the utensil while the firm manufactured (....) tablets."
The drug regulator further noted that the physical state of the manufacturing and processing buildings also drew severe criticism.
The FDA disclosed that these facilities were "not maintained in a good state of repair," pointing to cracks in manufacturing room walls and instances where surface damage was so severe that it exposed the concrete underneath. Such structural issues raise alarming concerns about the potential for mix-ups and contamination.
Dr. Reddy's is receiving additional criticism due to subpar quality control practices, insufficient written specifications, neglect in addressing batch failures and discrepancies, and inadequate responses to both written and oral customer complaints.
This stern action by the FDA underscores the gravity of the lapses at Dr. Reddy's and sends a clear message about the non-negotiable importance of adhering to stringent standards in pharmaceutical manufacturing. The Indian drugmaker now confronts the urgent need for rectification and the restoration of confidence in its practices to ensure the safety and well-being of consumers.