Robbins Instruments, LLC

Warning LetterOpen

Phu N. Nguyen Manager/Owner Robbins Instruments, LLC 2003 Edwards Street Houston , TX 77007 United States (b)(6)@robbinsinstruments.comFEI 2221941Issued Jan 21, 2025ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2221941.

Violations17

Issue DateJan 21, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Robbins Instruments, LLC
Location: Phu N. Nguyen Manager/Owner Robbins Instruments, LLC 2003 Edwards Street Houston , TX 77007 United States (b)(6)@robbinsinstruments.com
FEI Number: 2221941
Country: United States
Issue Date: January 21, 2025
Issuing Office: ORP: Office of Regulatory Programs, Office of Product Evaluation and Quality
Product Type: Medical Devices
Status: Open

Summary

Robbins Instruments, LLC manufactured and distributed the Dermo-Jet Needleless Injector without obtaining required FDA marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The company failed to submit a premarket approval application (PMA) or investigational device exemption, making the device adulterated, and did not notify FDA of its intent to introduce the device through a 510(k) submission, rendering it misbranded. An FDA inspection conducted from March through May 2024 at the company's Houston, Texas facility identified these violations during routine compliance investigation.

Robbins Instruments, LLC FDA Warning Letter, January 21, 2025