FDA 483 - Strive Pharmacy Texas LLC dba Strive Pharmacy - September 08, 2023

This FDA Form 483 document outlines observations made during an inspection of a pharmaceutical manufacturing facility. The inspection revealed several deficiencies related to facility design, personnel practices, and equipment sanitation, impacting the quality system and manufacturing processes.

A critical observation noted was the facility design allowing the influx of lesser quality air into a classified area containing higher quality air. This poses a significant risk to product sterility and quality.

Personnel performing aseptic manipulations were observed with exposed hair or skin, indicating a failure to adhere to proper gowning and aseptic techniques. This directly compromises the sterile environment and increases the risk of contamination.

Furthermore, the facility failed to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 5 area. This is a critical deficiency as the ISO 5 area requires the highest level of cleanliness to prevent microbial contamination of sterile products.

Finally, the cleaning of equipment and glassware was deemed inadequate. This broad observation suggests systemic issues with cleaning validation and routine cleaning procedures, potentially leading to product contamination or carry-over of residues.

These observations collectively indicate significant deficiencies in the facility's environmental controls, personnel training, and equipment maintenance, all of which are crucial for ensuring the quality and safety of manufactured products. The business and operational implications include potential regulatory actions, product recalls, and damage to reputation if these issues are not promptly addressed.