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# Multiple Optikem International Violations Cited
- URL: https://www.fdaweb.com/multiple-optikem-international-violations-cited/
- Published: 2024-09-10T12:00:00.000Z
- Updated: 2026-09-14T14:40:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157740

A 2/26-3/1 FDA inspection at the Optikem International facility in Denver, CO, found multiple violations in the firm’s manufacturing of the Sereine brand of ophthalmic medical device solutions. A just-released 8/13 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/optikem-international-inc-683606-08132024?ref=fdaweb.com) says the products are adulterated due to Quality System regulation violations. Specific violations cited were:

- failure to adequately validate processes used to produce devices labeled as “sterile”;
- failure to ensure equipment used to manufacture devices labeled as “sterile” is routinely calibrated according to regulations;
- failure to establish design control procedures and implement requirements to devices labeled as “sterile” according to regulations; and
- failure to establish corrective and preventive action procedures.

The firm’s responses to the inspection observations were not adequate, the letter says. FDA also says the firm’s products are adulterated because Optikem does not have an approved PMA or IDE and misbranded for failing to submit a 510(k). The agency also says the products are misbranded for failure to have a device identifier on the label and for failing to submit information to the Global Unique Device Identification Database.

Optikem was told to promptly correct the violations and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions, and a schedule for completing the corrections