FDA Issues 483 to New Jersey Sterile Drug Producer

Regulatory NewsRegulatory News | 07 November 2016

The US Food and Drug Administration (FDA) has released a Form 483 for New Jersey-based sterile and non-sterile drug producer PharmScript, detailing seven observations from an inspection of the company's Somerset, NJ facility in October.

Specifically, the Form 483 details issues that could lead to contamination, including improper gowning and handwashing by IV technicians, as well as issues related to the company's ISO 5 clean room.

Most of the seven observations in the 483 concern issues that could lead to contamination of drugs made at the site, including antibiotics vancomycin and mupirocin.

For instance, in the first observation FDA investigators said that technicians were free to "move in and out of the IV compounding room" through an unlocked door, with no written procedures to control movement between the areas.

In the second observation, FDA investigators note, "Garbing and hand washing is inconsistently and incorrectly performed by IV technicians. IV Technicians were observed to not wash forearms (to the elbows), not use sanitizer prior to placing gloves on, and don shoe covers last … An IV technician engaged in cleaning of the ISO 5 [Redacted] was observed with exposed wrists, facial hair, and clothing."

Additionally, the investigators said they observed employees using non-sterile disinfecting agents and cleaning wipes, and that the company did not use sporicidal agents to disinfect the ISO 5 area.

The company also failed to properly investigate deficiencies in temperature, pressure and humidity logs, and performed media fills that did not closely simulate aseptic production operations.

PharmScript did not respond to a request for comment yet.



© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy