Innovative Medical Manufacturing Co. FDA Record

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

  • Latest inspection VAI · Jan 29, 2015
  • Last warning letter 2010
Inspections 3 1 OAI
Recalls 0 0 Class I
Warning letters 1 Latest Dec 15, 2010
510(k) clearances 3 Latest Nov 5, 2013

Innovative Medical Manufacturing Co. has 0 FDA recalls, 3 inspections, 3 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Innovative Medical Manufacturing Co., the most recent on Dec 15, 2010.

What these totals cover: FDA records filed under the name "Innovative Medical Manufacturing Co." and its spelling variant "Innovative Medical Manufacturing".

Latest inspection
Jan 29, 2015 · VAI
Latest 510(k)
Nov 5, 2013

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) clearances3Nov 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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Innovative Medical Manufacturing Co. FDA Warning Letters

1 warning letter on Dec 15, 2010.

IssuedSubjectIssuing officeClose-out letter
Dec 15, 2010 · 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 12, 2010 to Jan 29, 2015.

DateSiteProductClassificationFEI
Jan 29, 2015Chunan Or Zhunan Township, TaiwanDevicesVoluntary Action Indicated (VAI)3003974574
Feb 23, 2012Chunan Or Zhunan Township, TaiwanDevicesVoluntary Action Indicated (VAI)3003974574
Aug 12, 2010Chunan Or Zhunan Township, TaiwanDevicesOfficial Action Indicated (OAI)3003974574
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 Innovative Medical Manufacturing Co.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Dec 15, 2010.

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 3003974574Chunan Or Zhunan Township, Taiwan3Jan 29, 2015

Recent 510(k) clearances

3 510(k) clearances from May 24, 2007 to Nov 5, 2013.

K-NumberDeviceDate
K131661INFUSION SYRINGE SETNov 5, 2013
K090727IMM DENTAL IRRIGATION TUBING SETAug 13, 2009
K070801IMM HYPODERMIC NEEDLE SETMay 24, 2007

Innovative Medical Manufacturing Co. and the FDA: common questions

Has Innovative Medical Manufacturing Co. received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Innovative Medical Manufacturing Co.. The most recent is dated Dec 15, 2010.

Has Innovative Medical Manufacturing Co. received an FDA Form 483?

FDA has not published a Form 483 for "Innovative Medical Manufacturing Co." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Innovative Medical Manufacturing Co.?

The most recent FDA inspection on file ended Jan 29, 2015 at Chunan Or Zhunan Township, Taiwan and was classified VAI. FDA has 3 inspections of Innovative Medical Manufacturing Co. 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.