Insanitary Conditions, Non-Aseptic Practices: Kilitch Recalls Several Eye Drops in US Read More..

USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA Investigators Justin A Boyd and Anastasia M Shields inspected the firm and observed several discrepancies in the manufacture of eye care products purported to be sterile. The USFDA 483 issued following the inspection cites processes and practices which compromise sterility of the drug products and do not assure control of microbial contamination of drug products manufactured. Observations include nonaseptic practices by operators in sterile filling lines – operators not wearing goggles, nose skin was exposed; non aseptic handling of bottles and caps in Grade A areas, bags of sterile components transferred from Grade B to Grade A area without disinfection, failure to follow gowning practices; An operator standing in the Grade A LAF hood for washing small filling machine parts was observed brushing his hair while in the hood.

Samples for Microbial monitoring (Environmental monitoring, personnel monitoring) are not always collected / tested but results are recorded within limits. Aseptic facilities are inadequate with turbulent airflow, deficient cleaning and disinfection procedures, mops used in the filling room are not sterilised, Material was observed escaping from drain lines in an area under Grade A LAF where components are sterilised.

Laboratory controls were inadequate with backdating of records by microbiologists, contact plates / settle plates had media desiccated and cracking, lapses in testing of drug product components, stability test methods were not stability indicating. QA processes were inadequate with inadequate qualification of API suppliers /API suppliers with no FDA registration, complaints were not handled adequately. Batches were released though process validation was not completed and only 3 months accelerated stability was completed.

The observations read like a list of what’s not to do in a drug manufacturing facility, let alone a sterile facility. Following the observations FDA asked Kilitch to recall the eyecare products and eye drops in US. Kilitch recalled 27 products which include products distributed by US retailers CVS, Walmart, Velocity, Target, Rite Aid etc. FDA had earlier warned consumers not to purchase or use store-brand eyedrops from Walmart Inc., CVS Health Corp., Target Corp. and others “due to risk of eye infection”

Recall Intimation

USFDA 483