USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia
The inspection concluded with the issuance of a form 483 with five observations
The inspection concluded with the issuance of a form 483 with five observations
The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories
The company has received the Certificate of GMP Compliance from the representative European inspection authority, Health Products Regulatory Authority (HPRA), Ireland.
The 562,000 square feet facility has been recognized as the first and largest integrated insulin manufacturer in Malaysia by MBR
Biocon Biologics’ Insugen formulations will be available to patients at all Ministry of Health hospitals, district health offices and health clinics
The company does not expect the outcome of this inspection to impact its plans
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