FDA WARNING_LETTER - Nurse Assist, Inc. - June 29, 2011

On June 21-29, 2011, an FDA inspection of Nurse Assist, Inc. in Fort Worth, Texas, revealed that their Enteral Infusion Pumps were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) current good manufacturing practice (CGMP) requirements.

Violations included: 1. **Complaint Handling (21 CFR 820.198(a)):** Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints. Of 65 Return Goods Authorizations (RGAs) from June 2009, 37 indicated device defects (e.g., hold errors, dose volume errors, flow problems), but none were documented as complaints or processed per the firm's complaint procedure. 16 of these 37 RGAs had no evaluation, investigation, or repairs, and devices were returned to inventory for sale. The firm's response to revise procedures was deemed inadequate as it didn't address a retrospective review of RGAs. 2. **Finished Device Acceptance (21 CFR 820.80(d)):** Failure to establish and maintain adequate procedures for finished device acceptance. The firm was not conducting the "Manufacturing Test Specification" for CPU printed circuit board assemblies during installation or