Contract Medical International Spol. Sr.O. FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

  • Latest inspection VAI · Nov 9, 2022
  • Last warning letter 2012
Inspections 3 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Dec 12, 2012
510(k) clearances 0 None on file

Contract Medical International Spol. Sr.O. has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Contract Medical International Spol. Sr.O., the most recent on Dec 12, 2012.

What these totals cover: FDA records filed under the name "Contract Medical International Spol. Sr.O." and its spelling variant "Contract Medical International Spol. Sr.O". Records filed under related names are not included; see Related names.

Latest recall
Z-2532-2025 · Jul 30, 2025 · filed under Contract Medical International
Latest inspection
Nov 9, 2022 · VAI

Newer recall under related name Contract Medical International: Jul 30, 2025, Z-2532-2025.

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 11, 2026 (checked Nov 15, 2026, unchanged)File dated Nov 10, 2026Current
510(k) clearances0Nov 15, 2026File dated Nov 9, 2026Current
Inspections3Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

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Contract Medical International Spol. Sr.O. FDA Warning Letters

1 warning letter on Dec 12, 2012.

IssuedSubjectIssuing officeClose-out letter
Dec 12, 2012 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Aug 9, 2012 to Nov 9, 2022.

DateSiteProductClassificationFEI
Nov 9, 2022Hradec Kralove 3, Czech RepublicDevicesVoluntary Action Indicated (VAI)3004563801
Jul 2, 2015Hradec Kralove 3, Czech RepublicDevicesNo Action Indicated (NAI)3004563801
Aug 9, 2012Hradec Kralove 3, Czech RepublicDevicesOfficial Action Indicated (OAI)3004563801
NAI
No objectionable conditions or practices were found during the inspection.
VAI
Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI
Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Contract Medical International Spol. Sr.O.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 12, 2012.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004563801Hradec Kralove 3, Czech Republic3Nov 9, 2022

Contract Medical International Spol. Sr.O. and the FDA: common questions

Has Contract Medical International Spol. Sr.O. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Contract Medical International Spol. Sr.O.. The most recent is dated Dec 12, 2012.

Has Contract Medical International Spol. Sr.O. received an FDA Form 483?

FDA has not published a Form 483 for "Contract Medical International Spol. Sr.O." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Contract Medical International Spol. Sr.O.?

The most recent FDA inspection on file ended Nov 9, 2022 at Hradec Kralove 3, Czech Republic and was classified VAI. FDA has 3 inspections of Contract Medical International Spol. Sr.O. on file, 1 of them classified OAI (official action indicated).

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