FDA 483 - SterRx, LLC - March 17, 2017

On March 17, 2017, the FDA issued a Form 483 to SterRx, an outsourcing facility located at 141 Idaho Ave, Plattsburgh, NY, following an inspection conducted from February 27, 2017, to March 17, 2017. The report was issued to Gary L. Hanley, O.D., Chief Executive Officer.

The inspection revealed several deficiencies in the firm's operations related to sterile ophthalmic drug production, including 1% Cyclopentolate HCl, 1% Tropicamide, and 2.5% Phenylephrine HCL.

**Key observations include:**

* **Environmental Monitoring Deficiencies (Observation 1):** The aseptic processing areas lacked adequate environmental monitoring. Specifically, there was no monitoring of non-viable particles in the ISO 5 critical fill zone during Blow Fill Seal (BFS) operations, the (b)(4) was not certified at the point of use, surfaces within the critical fill zone were not sampled, and personnel engaged in BFS manufacturing were not monitored. * **Inadequate Sterilization Process Validation (Observation 2):** Procedures to prevent microbiological contamination were deficient due to inadequate validation of the sterilization process. The product (b)(4) validation did not evaluate a worst-case representative product, and the (b)(4) evaluation did not include the firm's standard practice of (b)(4