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# QS Violations at Orchid Orthopedic
- URL: https://www.fdaweb.com/qs-violations-at-orchid-orthopedic/
- Published: 2019-05-21T12:00:00.000Z
- Updated: 2026-09-15T01:28:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144154

A 2/4-2/15 FDA inspection at Orchid Orthopedic Solutions, Farmington Hills, MI, found Quality System Regulation violations in the firm’s work as a medical device manufacturer specializing in applying coatings to orthopedic implants that promote bone ingrowth. A 5/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/orchid-orthopedic-solutions-llc-580112-05132019?ref=fdaweb.com) says the specific violations were: 

- failing to establish and maintain procedures to control product that does not conform to specified requirements;
- failing to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
- failing to establish and maintain procedures for implementing corrective and preventive action;
- failing to adequately validate a process whose results cannot be fully verified by subsequent inspection and test;
- failing to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit; and
- failing to adequately establish processes for quality audits.

Orchid was told to respond with a list of specific steps taken to correct the violations and prevent those or similar violations from occurring in the future, with documentation of the corrections and/or corrective actions, and a timetable for completion.