FDA warns Orchid Orthopedics about Michigan facility compliance: 3 details

Written by Laura Dyrda | May 22, 2019 | Print  |

The FDA sent a warning letter to Orchid Orthopedics CEO Jerry Jurkiewicz concerning its operations in Farmington Hills, Mich.

 

Three things to know:

1. The FDA conducted an inspection of the company's facility in Farmington Hills in February and determined that the facility did not meet the "current good manufacturing practice requirements" set forth by the quality system regulations. Specifically, the agency found Orchid had an undocumented change to water monitoring procedures corrective plan and it did not regularly analyze rework shop orders for products that didn't meet certain specifications, according to FDA News.

2. Orchid initially responded to the letter in March, but the FDA was either unable to assess the changes or found the response inadequate for most points addressed in the letter.

3. The FDA then responded with a warning letter dated May 21 advising the company to "take prompt action to correct the violations addressed in the letter" or face regulatory action. The FDA asked for a written explanation of the steps Orchid has taken to correct violations and explanation of how it will prevent future violations within 15 days of receiving its warning letter.

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