FDA 483 - merissa corp. - May 28, 2015

This FDA Form 483 was issued to Merissa Corp. DBA Johnson Compounding and Wellness, a producer of sterile drugs located at 577 Main St, Waltham, MA 02452-5527. The inspection was conducted from May 11, 2015, to May 28, 2015. Diane M. Bernardi, Co-Owner and Pharmacist, was the recipient of the report.

The inspection revealed six observations related to deficiencies in aseptic processing and quality control:

1. **Aseptic processing areas are deficient regarding systems for maintaining equipment used to control aseptic conditions.** Dynamic airflow pattern evaluations (smoke studies) for ISO 5 classified areas did not demonstrate unidirectional airflow at critical sites under worst-case conditions, failing to include all equipment and component configurations. 2. **Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.** The aseptic simulation (media fill) program was inadequate, as it did not simulate all routine aseptic manipulations or the most challenging conditions, specifically omitting processes for certain Alprostadil preparations and aseptic filling of open vials. 3. **Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.** Environmental and personnel monitoring frequencies were inadequate. This included insufficient sampling of meaningful surface sites in ISO 5 and ISO 7 areas, infrequent viable air monitoring in ISO 5