FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

CellEra, LLC

CellEra, LLC is an FDA-registered device establishment (FEI 3007594734) located in Monroe, Ohio. The facility is active, registered. Its most recent FDA inspection on record (2022-04-14) was classified VAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Oct 20, 2021
CGMP/QSR/Medical Devices/Adulterated
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (2)

Dec 15, 2021 Class III
Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the corre
TerminatedView source data ›
Sep 1, 2016 Class II
Adhesive border was not sticky enough.
TerminatedView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3007594734
Address
1045 Reed Road, Monroe, Ohio
Establishment type
Device establishment
Products / operations
Unknown, Complaint File Establishment per 21 CFR 820.198, General, Plastic Surgery, General Hospital, Clinical Chemistry
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Apr 14, 2022 · Voluntary Action Indicated (VAI)
Jul 8, 2021 · Official Action Indicated (OAI)
May 30, 2019 · Voluntary Action Indicated (VAI)
Form 483 observations
Apr 14, 2022, 4 observations: Lack of or inadequate complaint procedures; Lack of or inadequate procedures - Acceptance activities; Lack of or inadequate procedures
Jul 8, 2021, 8 observations: Design control - no procedures; Lack of or inadequate procedures; Lack of Written MDR Procedures
May 30, 2019, 7 observations: Purchasing controls, Lack of or inadequate procedures; Lack of or inadequate complaint procedures; Design control - no procedures

FDA record timeline

FDA inspection
VAI classification
Form 483
4 observations
Recall
Class III — Firm discovered that an incorrect version of the Instructions for Use (IFU) containing language beyond the cleared 510(k) were inserted in the affected products. Firm is replacing these with the corre
Source ›
Warning letter
CGMP/QSR/Medical Devices/Adulterated
Source ›
FDA inspection
OAI classification
Form 483
8 observations
FDA inspection
VAI classification
Form 483
7 observations
Recall
Class II — Adhesive border was not sticky enough.
Source ›

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is CellEra, LLC registered with the FDA?

Yes. CellEra, LLC is an FDA-registered device establishment (FEI 3007594734) in Monroe, Ohio. Its current registration status is Active, Registered.

Has CellEra, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to CellEra, LLC; the most recent is dated Oct 20, 2021 (CGMP/QSR/Medical Devices/Adulterated).

What does CellEra, LLC do?

CellEra, LLC's FDA-registered operations are: Unknown, Complaint File Establishment per 21 CFR 820.198, General, Plastic Surgery, General Hospital, Clinical Chemistry.

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Source: FDA public data · status as of 2026-08-22

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