# FDA 483 - Optikem International, Inc. - July 11, 2022

Source: https://www.globalkeysolutions.net/records/483/optikem-international-inc/c33e3e91-011e-4a95-931c-b91031e09118

> FDA 483 for Optikem International, Inc. on July 11, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Optikem International, Inc.
- Inspection Date: 2022-07-11
- Product Type: device
- Office Name: Denver District Office
- Summary: Optikem International, Inc., a medical device manufacturer in Denver, CO, received two observations during an FDA inspection from July 6-11, 2022. The firm failed to adequately establish and follow procedures for routine equipment calibration, particularly for time-temperature control devices. Additionally, the company has not implemented Unique Device Identifier (UDI) requirements for its medical device products, despite prior FDA guidance.

## Related Documents

- [483 - 2024-03-01](https://www.globalkeysolutions.net/records/483/optikem-international-inc/de795f53-0728-4b7e-8d57-f199637e8488)
- [WARNING_LETTER - 2024-03-01](https://www.globalkeysolutions.net/records/warning_letter/optikem-international-inc/625a1a60-a342-4dcf-b29f-fdfe98666300)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

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

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