# FDA 483 - Optikem International, Inc. - March 01, 2024

Source: https://www.keypedia.com/records/483/optikem-international-inc/de795f53-0728-4b7e-8d57-f199637e8488

> FDA 483 for Optikem International, Inc. on March 01, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optikem International, Inc.
- Inspection Date: 2024-03-01
- Product Type: device
- Office Name: Denver District Office
- Summary: Optikem International, Inc. in Denver, CO, a medical device manufacturer, was cited for significant deficiencies across multiple quality system areas during an FDA inspection. The inspection revealed inadequate validation of aseptic processes and equipment, poorly established environmental controls, and a lack of routine equipment calibration. Furthermore, the firm failed to establish adequate procedures for corrective and preventive actions, design validation, risk analysis, and design verification for its Class II medical devices, with some issues being repeat observations from previous inspections.

## Related Documents

- [483 - 2022-07-11](https://www.keypedia.com/records/483/optikem-international-inc/c33e3e91-011e-4a95-931c-b91031e09118)
- [WARNING_LETTER - 2024-03-01](https://www.keypedia.com/records/warning_letter/optikem-international-inc/625a1a60-a342-4dcf-b29f-fdfe98666300)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/optikem-international-inc/6d89f8c9-2ba5-4826-a8e3-e71a5a10fb3e

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face