Madhu Instruments Private Limited
FDA issued a warning letter to Madhu Instruments Private Limited (New Delhi, India) following a 2022 inspection that found sterile drug products manufactured under insanitary conditions, including peeling paint, blocked HEPA filters, broken tiles with residue, visibly dirty equipment, and improvised patching materials in ISO 7 manufacturing rooms. The firm's corrective response was deemed inadequate for failing to conduct a retrospective risk assessment or develop a sufficient cleaning and sanitization regimen. FDA had already placed the firm on Import Alert 66-40 as of May 31, 2023, subjecting its products to detention or refusal of admission into the United States. The letter requires a written response within 15 working days with documented corrective actions.
Required actions (4)
FDA placed your firm on Import Alert 66-40 on May 31, 2023.
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any violations are completely addressed and we confirm your compliance with the Act.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Madhu Private Limited, A-260, Okhla Industrial Area, Phase-1, New Delhi, India, into the United States under section 801 of the FD&C Act, 21 U.S.C. 381.
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