# FDA 483 - CellEra LLC - April 14, 2022

Source: https://www.keypedia.com/records/483/cellera-llc/5cab53fe-f838-4cf0-9a8d-e4b59ff64dda

> FDA 483 for CellEra LLC on April 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellEra LLC
- Inspection Date: 2022-04-14
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: CellEra LLC, an initial importer in Monroe, OH, was inspected by the FDA from April 11-14, 2022. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning the lack of established procedures for complaint handling, acceptance activities, corrective and preventive actions (CAPA), and Medical Device Reporting (MDR). These issues indicate a systemic failure to implement fundamental quality control processes.

## Related Documents

- [483 - 2019-05-30](https://www.keypedia.com/records/483/cellera-llc/26a2b033-9516-4de8-8c61-428d823180db)
- [483 - 2021-07-08](https://www.keypedia.com/records/483/cellera-llc/e6ca7010-f62b-4e2d-a036-3b49327cf58e)
- [WARNING_LETTER - 2021-07-08](https://www.keypedia.com/records/warning_letter/cellera-llc/39cd0f2b-d596-4929-a68c-be4c604f569a)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.keypedia.com/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)
- [Amber M. Capello-Jones](https://www.keypedia.com/people/amber-m-capello-jones/d34f92a0-d580-4028-9d31-c6cd7c13ce0f)

Company: https://www.keypedia.com/companies/cellera-llc/b249865e-010e-4d96-886f-a41f9587c80f

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22