USFDA 483 /Dr.Reddys (DRL) / October 2023 / Cleaning deficiencies, building maintenance issues

Observation 1

Deficient cleaning practices, presence of actives from previously manufactured products in floor / equipment surface swabs, tablet samples.

·        Observed spillage, residues, colour on the floor underneath equipment which were identified as from previously and recently manufactured products by production operators and IPQA employees. Analysis of the samples showed presence of (active) peaks in HPLC /LC-MS / MS chromatograms

·        Surface swabs from equipment product contact and non contact areas showed presence of (active) peaks. Analysis of drug product samples (Tablets) also showed presence of (other active) peaks in HPLC chromatograms. There is also potential for the carry over material (from previous products) to react with drug product components and form unknown impurities during products shelf life.

·        Equipment (In manufacturing area) were not cleaned underneath the mounted platform since installation and there is potential for material deposit and microbial growth in these areas. Layers of residues, wet areas were observed underneath the mounted platform and the material can deposit on machine components over several years due to positive pressure in the manufacturing area. Swab samples from underneath the platform also showed fungal growth

·        Cracks were observed during inspection of manufacturing module and there is chance of tiny particle from the cracks introduced into the products manufactured.