Home / Facilities / 1000639866

CODONICS, INC. FDA Inspection Record

FEI 1000639866 · Inspections, Form 483s, warning letters and import refusals

CODONICS, INC. is an FDA-registered facility (FEI 1000639866) located in Middleburg Heights, OH, US. RegDataLab tracks 3 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 21, 2025: No Action Indicated (NAI)
Inspections on record
3 (3 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 21, 2025No Action Indicated (NAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Procedures not adequately established or maintained (21 CFR 820.40)
Lack of or inadequate procedures (21 CFR 820.100(a))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
Apr 15, 2016No Action Indicated (NAI)Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a))
Purchasing controls, Lack of or inadequate procedures (21 CFR 820.50)
Dec 2, 2011No Action Indicated (NAI)No citations listed

FDA record score

0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. No OAI or VAI inspection, warning letter, Class I or II recall, or counted import refusals for this FEI in the records we hold.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

Reviewing CODONICS, INC. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check CODONICS, INC. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Codonics Inc
Location
Middleburg Heights, OH (US)
Source
device

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.