PharmScript, LLC – FDA 483, Oct 24, 2016

This FDA Form 483 was issued to PharmScript, LLC, a producer of non-sterile and sterile drug products located at 150 Pierce Street, Somerset, NJ 08873-4185. The inspection was conducted from October 4, 2016, to October 24, 2016. Mr. John F. Walker, COO, was the recipient of the report.

The inspection revealed several observations related to quality systems and manufacturing practices:

**Observation 1:** The ISO 5 classified area's design allowed uncontrolled movement of personnel, lacking procedures for gowning and handwashing during aseptic processing. Deficiencies in environmental monitoring included unrecorded checks for HEPA filter integrity, and continued production despite documented excursions in temperature/pressure/humidity logs without investigation. Specific examples include incorrect pressure readings, zero pressure readings, and loss of positive pressure, leading to the production and dispensing of numerous prescriptions under compromised conditions.

**Observation 2:** Personnel exhibited improper gowning and handwashing techniques. IV technicians did not wash forearms to elbows, failed to use sanitizer before gloving, and donned shoe covers last. Gloves were non-sterile and did not properly overlap with non-sterile, open-backed gowns. Exposed wrists, facial hair, and clothing were observed on an IV technician cleaning the ISO 5 area.

**Observation 3:** The ISO 5 area was not certified under dynamic conditions, specifically