WARNING LETTER
Robbins Instruments, LLC was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:
CMS# 687984
2003 Edwards Street
Houston, TX 77007 United States
Dates: March 27 through May 31, 2024
Inspection Issue(s):
The report states that, “FDA has learned that your firm is marketing the Dermo-Jet Needleless Injector without marketing clearance or approval, in violation of the Act.” FDA has determined, based on information provided by your firm that the Dermo-Jet Needleless Injector is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B).”
“The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).”
“Specifically, the instructions for use document for the Dermo-Jet Needleless Injector included in the company’s SOP document provided during the referenced inspection outlines the following indications: “The DERMO-JET is a versatile, time-tested, medical instrument for administration of sub-topical injections of parenteral medicaments, anesthetic solutions, steroids in aqueous suspension, soluble drugs, vaccines, antibiotics, etc.”
The report also includes but is not limited to:
- Your firm has not established a design change procedure. Your firm updated the sterilization instruction in your instruction for use (IFU) without identification, documentation, validation or where appropriate verification, review and approval of design changes before their implementation.
- Your firm has not established a complaint handling procedure.
- your firm has not established procedures for acceptance activities such that inspections, tests, or other verification activities are performed to ensure compliance with specified requirements.
- Failure to establish procedures to control labeling activities.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
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