Indoco Remedies Limited — FDA Warning Letter Findings

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). Your investigations into product quality defect complaints are not consistently and scientifically supported and rely on flawed analyses to reach conclusions on product quality impact. For example: A. Your investigation into complaints of dispensing tip (nozzle) blockage associated with (b)(4) solution USP (b)(4) % ( (b)(4) ) and (b)(4) and (b)(4) solution USP, (b)(4) mg/ml and (b)(4) mg/mL ( (b)(4) ) concluded the tip blockage phenomena was due to improper storage by patients. You stated the ensuing exposure of product solutions to air resulted in the (b)(4) excipient in the formulations forming a film or precipitating and blocking the dispensing tips. Your investigation is deficient for reasons including, but not limited to…

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Our review found deficiencies in video recordings of airflow (smoke) studies executed in the ISO 5 areas including on Line (b)(4) at the empty vial (b)(4) and the nozzle (b)(4) . Specifically, the presence of…

Neither of the scientific publication sources cited in your investigation support your root cause.

Your firm failed to establish an adequate system for maintaining equipment used to control the aseptic conditions (21 CFR 211.42(c)(10)(vi)). Our review found unsuitable conditions in ISO 5 areas where aseptic processing is conducted. For example: A. Rough metal surfaces and an incomplete (b)(4) were observed on the Line (b)(4) Restricted Access Barrier System (RABS) framework in the area above the stopper loading chute. B. (b)(4) or (b)(4) were observed protruding through…

Your experimental study compared the effect of atmospheric exposure of a freshly prepared solution by your research and development group against samples of innovator product that expired approximately 2.5 years earlier. B. Your investigations into complaints of (b)(4) and (b)(4) drug products missing tips or being received empty by patients were repeatedly determined to have no impact on product quality. This conclusion conflicts with the finished product quality attributes…

Your firm failed to record and justify any deviations from required laboratory control mechanisms (21 CFR 211.160(a)). You lacked adequate controls to assure the reliability of microbiological testing results. For example: A. Numerous non-viable dark particles were observed in (b)(4) plates used for microbiological analyses in your laboratory. B. Non-viable dark particles were observed on filter (b)(4) used for (b)(4) microbiological testing. C. Media plates prepared…

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Warning and error messages in the Empower Message Center included in your chromatography data software are not reviewed. For example, during the 20-day period between December 26, 2023, and January 15, 2024, the following error messages were registered in the Empower…