Changchun New Industries Optoelectronics Tech. Co., Ltd. FDA Record

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

Changchun New Industries Optoelectronics Tech. Co., Ltd. has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Changchun New Industries Optoelectronics Tech. Co., Ltd." is on file.

What these totals cover: FDA records filed under the name "Changchun New Industries Optoelectronics Tech. Co., Ltd." and its spelling variant "Changchun New Industries Optoelectronics Tech. Co".

Latest inspection
May 23, 2011 · VAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections2Nov 14, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

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Recent FDA inspections

2 inspections from Apr 13, 2009 to May 23, 2011.

DateSiteProductClassificationFEI
May 23, 2011Changchun, ChinaDevicesVoluntary Action Indicated (VAI)3002756898
Apr 13, 2009Changchun, ChinaDevicesNo Action Indicated (NAI)3002756898
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.

FDA-inspected facilities

1 inspected site, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3002756898Changchun, China2May 23, 2011

Changchun New Industries Optoelectronics Tech. Co., Ltd. and the FDA: common questions

Has Changchun New Industries Optoelectronics Tech. Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "Changchun New Industries Optoelectronics Tech. Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Changchun New Industries Optoelectronics Tech. Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "Changchun New Industries Optoelectronics Tech. Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Changchun New Industries Optoelectronics Tech. Co., Ltd.?

The most recent FDA inspection on file ended May 23, 2011 at Changchun, China and was classified VAI. FDA has 2 inspections of Changchun New Industries Optoelectronics Tech. Co., Ltd. on file.

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