Drugs

FDA Cites Manufacturing, Quality Lapses at Orchid Pharma

FDA has cited significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient (API) facility operated by Orchid Pharma Limited in India, following an inspection last year.

According to the just-posted 2/18/2025 FDA Form 483, inspectors identified multiple lapses at the company’s plant in Alathur, Tamil Nadu, which manufactures APIs for the U.S. market. The inspection outlines seven observations spanning cleaning validation, process controls, equipment qualification, and data integrity.

Among the issues, FDA investigators said the company failed to adequately validate cleaning procedures for non-dedicated equipment used in sterile manufacturing. Inspectors noted the absence of established clean hold times and sterile hold times, raising concerns about whether equipment remained free of microbial contamination and endotoxins prior to reuse.

The agency also reported that the firm lacked sufficient data to ensure sterility of certain equipment before production, despite having manufactured and shipped multiple API batches to the U.S. between 2021 and 2024. In addition, cleaning procedures were described as insufficiently detailed, relying on batch records that lacked step-by-step instructions for disassembly, cleaning, and reassembly. In one instance, visible residue was detected on equipment surfaces despite being documented as clean.

FDA also cited failures in process validation, including reliance on concurrent validation approaches that did not adequately demonstrate reproducibility. Sampling strategies were also criticized for relying on averaged data, which regulators said obscured variability and failed to demonstrate uniformity across production batches.

The agency further noted that written procedures were not adequately established to ensure manufacturing processes consistently produce APIs meeting predetermined quality attributes.

Additionally, the inspection identified weaknesses in data controls, including laboratory equipment that did not retain electronic test data despite having that capability. Instead, analysts printed results and manually recorded them without secondary verification, raising concerns about data integrity. The agency also found lapses in quality unit oversight, including overdue good manufacturing practice training for personnel.

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