# FDA WARNING_LETTER - CellEra LLC - July 08, 2021

Source: https://www.keypedia.com/records/warning_letter/cellera-llc/39cd0f2b-d596-4929-a68c-be4c604f569a

> FDA WARNING_LETTER for CellEra LLC on July 08, 2021. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: CellEra LLC
- Inspection Date: 2021-07-08
- Product Type: Devices
- Office Name: Office of Medical Device and Radiological Health Division 1 – East
- Summary: On October 20, 2021, the FDA issued a Warning Letter to CellEra LLC following an inspection from June 16 to July 8, 2021, at their Monroe, OH facility. The inspection revealed that CellEra LLC, a specification developer and own-label distributor of sterile wound dressings with drug, had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

The letter detailed numerous repeated violations from a May 30, 2019, FDA 483 and a January 14, 2020, Regulatory Meeting. Key violations include:
1. **Failure to establish and maintain CAPA procedures (21 CFR § 820.100):** Undocumented corrective actions, including changes to Instructions for Use (IFUs) for Vitále Silver Calcium Alginate wound dressing that still contained uncleared claims.
2. **Failure to establish and maintain design control procedures (21 CFR § 820.30):** Lack of procedures for design inputs, outputs, verifications, validations, reviews, transfers, changes, and a design history file.
3. **Failure to control design changes (21 CFR § 820.30(i)):** Numerous undocumented design

## 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)
- [483 - 2022-04-14](https://www.keypedia.com/records/483/cellera-llc/5cab53fe-f838-4cf0-9a8d-e4b59ff64dda)

## Related Officers

- [Ken Heyl](https://www.keypedia.com/people/ken-heyl/1a6988aa-6a82-42da-8b4f-12697e75b0d7)
- [Arduino Frankovic](https://www.keypedia.com/people/arduino-frankovic/d5ac3ff7-bd26-4832-a1b4-fbe3f7de07f4)

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-1-east/2f4357de-bb7c-482b-bb07-a832f02b928b