Indoco Remedies Limited (Plant I)January 25, 2019

FDA 483 - Indoco Remedies Limited (Plant I) - January 25, 2019

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Record Details

Indoco Remedies Limited (Plant I) in Vasco Da Gama, Goa, a tablet manufacturer, was inspected and cited for significant data integrity issues and inadequate quality control. Observations included purposeful recording of inaccurate manufacturing data, failure to thoroughly investigate discrepancies and OOS results, and incomplete laboratory and batch records. The inspection revealed systemic problems in data management, record-keeping, and procedural adherence.

Company: Indoco Remedies Limited (Plant I)
Inspection Date: January 25, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Justin A. Boyd (Research Specialist II)
Rumany C. Penn (Compliance Officer)

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ID · 6817f714-58eb-49a0-bd22-621d560a785e