As per USFDA Sun, pharma failed to maintain and clean equipment used for drug manufacturing at its Dadra-based manufacturing plant. On June 18, managing director Dilip Shangvi got a warning letter on June 18, the US regulator stated that they inspected the plant in Dadra Nagar Haveli and Daman.
The USFDA said that your firm failed to clean, maintain, and as appropriate for the nature of the drug, sanitise and/or sterilised equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter safety, identity, strength, quality, or purity of drug product beyond the official or other established requirements.
The warning letter mentioned violating the Current Good Manufacturing Practice regulations for finished products. In a warning letter, the USFDA noted inadequate investigation of out-of-service results because they lacked scientific root cause determinations.
It stated that the manufacturing facility failed to investigate any unexplained discrepancy or any of its components to meet any of its specifications. When the US health regulators find that a manufacturer has significantly violated its regulations.
The US health regulator stated, “The company’s committed to conducting a comprehensive assessment of your global manufacturing operation across your company’s network to ensure conformance to FDA requirements. These repeated failures at multiple sites demonstrate that management oversight and control over the manufacture of drugs is inadequate. We strongly recommended that your firm engage a consultant to assist your firm in meeting CGMP requirements”.
It further stated that the FDA may withhold approval of new applications or supplements listing manufacturing firms as drug manufracturer until any deviations are completely addressed and the USFDA confirm the firm’s compliance with CGMP. They may re-inspect to verify that the firm has completed corrective action to any deviations.
It said to respond to this office in writing within 15 working days after the company receives this letter.
The warning letter issued by the USFDA usually specifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect direction for use. The letter also clearly mentioned that the company must clear its problem.
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