FDA 483 - Biocon Sdn. Bhd. (Company No. 201101002193) - August 30, 2022

This FDA Form 483 details numerous observations from an inspection, highlighting deficiencies in aseptic processing, quality control, and manufacturing practices.

**Aseptic Process and RABS Issues:** * Aseptic process simulations and smoke studies are not representative of routine operations. Examples include RABS (Restricted Access Barrier System) doors open for extended periods or multiple doors open simultaneously during setup and filling, which were not simulated. * Assembly procedures for stopper insertion and tightening differed from smoke study observations. * An operator left a RABS door inadvertently open during line installation. * Operators contacted fixed equipment and RABS doors without spray sanitizing. * Operators resumed operations inside RABS before gloves dried completely after sanitizing. * Operators touched both sides of a sterile equipment bag after sanitizing only the top surface. * Unidirectional laminar flow was blocked by an opened bag with a large surface area. * Operators' goggles had three open vents. * Operators moved abruptly and rapidly inside the RABS and during wipe-down.

**Cleaning and Disinfection Validation:** * Cleaning procedures for non-product-contact equipment in RABS are not validated, with manual cleaning lacking assurance of consistency with validation studies. * Disinfectant efficacy study for RABS decontamination was not performed in the Grade A RABS. * Cleaning verification is only performed on product-contact surfaces, lacking verification for hard-to