# FDA 483 - CellEra LLC - May 30, 2019

Source: https://www.globalkeysolutions.net/records/483/cellera-llc/26a2b033-9516-4de8-8c61-428d823180db

> FDA 483 for CellEra LLC on May 30, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CellEra LLC
- Inspection Date: 2019-05-30
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Cellkera LLC, a medical device manufacturer in Monroe, OH, was inspected by the FDA from May 28-30, 2019. The inspection revealed significant deficiencies across its quality system, including a lack of established procedures for purchasing controls, acceptance activities, corrective and preventive actions, complaint handling, MDR reporting, design control, and environmental controls for sterile product storage. These issues indicate a broad failure to maintain adequate quality system processes for medical device manufacturing.

## Related Documents

- [483 - 2021-07-08](https://www.globalkeysolutions.net/records/483/cellera-llc/e6ca7010-f62b-4e2d-a036-3b49327cf58e)
- [WARNING_LETTER - 2021-07-08](https://www.globalkeysolutions.net/records/warning_letter/cellera-llc/39cd0f2b-d596-4929-a68c-be4c604f569a)
- [483 - 2022-04-14](https://www.globalkeysolutions.net/records/483/cellera-llc/5cab53fe-f838-4cf0-9a8d-e4b59ff64dda)

## Related Officers

- [Consumer Safety Officer, Medical Device Specialist](https://www.globalkeysolutions.net/people/teresa-kastner/32a8d75e-770d-48cc-80e0-2eb5ad57e560)

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

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