GE Healthcare Shanghai Co., Ltd. FDA Record

Summary

FDA record by year

GE Healthcare Shanghai Co., Ltd.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Related names

Each name below has its own page. Its counts cover only the records FDA filed under that name and are not part of the totals for GE Healthcare Shanghai Co., Ltd. above.

GE Healthcare Shanghai Co., Ltd. and the FDA: common questions

Has GE Healthcare Shanghai Co., Ltd. received an FDA warning letter?

No FDA warning letter addressed to the name "GE Healthcare Shanghai 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 GE Healthcare Shanghai Co., Ltd. received an FDA Form 483?

FDA has not published a Form 483 for "GE Healthcare Shanghai Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect GE Healthcare Shanghai Co., Ltd.?

The most recent FDA inspection on file ended Oct 30, 2025 at Shanghai, China and was classified VAI. FDA has 6 inspections of GE Healthcare Shanghai Co., Ltd. on file.