Bhaumik Diversified LLC dba Texas Star Pharmacy — FDA 483 Findings

Visibly dirty utensils used in the production of non-sterile drug products.

You used a non-pharmaceutical grade component in the formulation of a drug product .

Non-sterilized equipment was used in sterile drug production.

Personnel failed to disinfect or change gloves frequent enough to prevent contamination.

Use of non-sterile <Redacted B4> in ISO-classified areas.

You used a non-pharmaceutical grade detergent, non-sterile disinfectant to clean glassware and equipment used in the production of sterile injectable and non-sterile drug products.

You produced hazardous and potent drugs without providing adequate segregation and cleaning of utensils to prevent cross-contamination.

Non-microbial contamination was observed in your production area.

Stock solutions are not adequately prepared for use in sterile drug preparations to prevent proliferation of microbes.

Smoke studies performed under dynamic conditions are inadequate.

Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.