# FDA 483 - Robbins Instruments, LLC - May 31, 2024

Source: https://www.globalkeysolutions.net/records/483/robbins-instruments-llc/7f0abbb4-032c-4349-940b-3e884185f726

> FDA 483 for Robbins Instruments, LLC on May 31, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robbins Instruments, LLC
- Inspection Date: 2024-05-31
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Robbins Instruments, LLC, an initial importer and assembler of the Dermo-Jet Needleless Injector, was cited for significant quality system deficiencies during a March 2024 inspection. The firm lacked validated sterilization processes, proper design controls, and a functional complaint handling system, leading to uninvestigated device failures and inadequate MDR reporting. Overall, the inspection revealed a pervasive lack of established procedures and documentation across critical quality system elements, including device history records, acceptance activities, servicing, labeling, management review, and quality audits.

## Related Documents

- [WARNING_LETTER - 2024-05-31](https://www.globalkeysolutions.net/records/warning_letter/robbins-instruments-llc/a984f944-a8b9-4349-a2a0-b7bab335c6f3)

## Related Officers

- [Jocelyn C. Turner](https://www.globalkeysolutions.net/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.globalkeysolutions.net/companies/robbins-instruments-llc/f7b8ef88-211f-41b0-a77e-20df43b2d6fb

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab