FDA 483 - RX South DBA RX3 Compounding Pharmacy LLC - February 21, 2014

The FDA Form 483 details numerous repeat observations and deficiencies at a facility producing sterile injectable drug products, including Prostaglandin E-1, Triple-Mix, Hydroxyprogesterone Caproate, Estradiol Pellets, and Testosterone Pellets.

Key violations include inadequate validation of sterilization processes for drug products and process equipment, such as depyrogenation. Procedures for verifying sterilization effectiveness are not consistently followed, and results are not always documented. The water supply for sterilization is not tested for endotoxins or sterility.

Environmental monitoring is insufficient; microbiological monitoring of ISO 5 filling hoods is not performed daily, and non-viable particulate and active/passive microbial air monitoring are only conducted during HEPA requalifications. Technician glove monitoring is also infrequent.

The facility lacks written procedures for production and process controls, and production processes, including mixing times, are not adequately validated. Gowning procedures are deficient, with non-sterile attire and exposed hair observed. Materials are not consistently disinfected before entering cleanrooms.

Airflow studies are incomplete, lacking evaluation of laminarity and documentation of dynamic conditions. Continuous monitoring of air pressure differentials is absent. The suitability of disinfecting agents and procedures has not been assessed, and non-sterile disinfectants are used. Incubator temperature monitoring is infrequent, and no audit of the contract testing laboratory has been conducted.