empower clinic services, llc, – FDA EIR, Jan 24, 2018

An FDA inspection of Empower Clinic Services, LLC, a 503B outsourcing facility, was conducted from January 10 to January 24, 2018. The inspection, a high-priority review following a facility relocation, focused on the firm's compounding and distribution of sterile injectable drug products and non-sterile patient-specific prescriptions across all fifty states.

The primary issue identified during this 2018 inspection was a critical lapse in quality control: the firm's failure to thoroughly investigate drug product batches that did not meet specifications. This resulted in a one-item FDA Form 483 observation. This observation follows a pattern of compliance challenges for Empower Clinic Services. A previous inspection in late 2015, when the firm operated as a 503A facility, resulted in a seven-item FDA Form 483, citing numerous deficiencies. These included inadequate review of out-of-specification batches, insufficient validation of sterilization processes, and significant issues with environmental monitoring, equipment maintenance, cleaning, and air filtration within aseptic processing areas. Furthermore, in May 2017, the firm received a warning letter for not obtaining valid individual patient prescriptions for certain products and for general deficiencies in sterile drug production.

In response to the latest FDA Form 483, company management committed to submitting a written response within fifteen business days. This indicates a required action for the firm to address the identified quality system deficiencies and demonstrate adherence to regulatory standards for drug compounding and manufacturing.