FDA 483 - lincare, inc. - August 22, 2017

On August 22, 2017, the FDA issued a Form 483 to Lincare, Inc. dba United Medical Home Infusion, located at 1527 South Bowman Road Suite D, Little Rock, AR 72211-4200. The inspection, conducted by Investigator Jason R. Caballero, took place from August 14-22, 2017. The facility is identified as a producer of sterile drug products.

The sole observation noted during the inspection was:

**Observation 1:** A disinfecting agent used in the ISO 5 areas is not sterile. Specifically, the firm utilizes a non-sterile disinfectant in the ISO 5 areas, which is applied on a regular basis in the firm's laminar airflow hoods.

This observation indicates a potential quality system and manufacturing issue related to maintaining aseptic conditions in critical sterile processing environments. The use of a non-sterile disinfectant in ISO 5 areas, which are designed for sterile operations, could compromise the sterility of drug products produced. The document does not specify any regulatory citations but highlights a deficiency in the firm's control over its sterile manufacturing environment.