Xiamen Tiger Medical Company, Ltd.
Form 483 issued December 19, 2023 · Xiamen, China
- Inspection
- Dec 14 – Dec 19, 2023
- Investigators
- Hung H. Do· Marcellinus D. Dordunoo
- Observations
- 6
- Pages
- 5
- FEI number
- 3012323390
In short: On December 19, 2023, FDA issued a Form 483 with 6 observations to Xiamen Tiger Medical Company, Ltd. in Xiamen, Fujian (FEI 3012323390) after an inspection that ran Dec 14 – Dec 19, 2023. The investigators were Hung H. Do and Marcellinus D. Dordunoo. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
Sampling and testing plans for drug products are not described in written procedures which include the…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Investigations of a failure of a batch or any of its components to meet any of…
This inspection in context
Hung H. Do
11 documents · 2021–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmXiamen Tiger Medical Company, Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Xiamen Tiger Medical Company, Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Xiamen Tiger Medical Company, Ltd.?
Hung H. Do and Marcellinus D. Dordunoo are named on this Form 483, for the inspection of Dec 14 – Dec 19, 2023. Each investigator has a profile showing what they cite most.
When was Xiamen Tiger Medical Company, Ltd. inspected by FDA?
The inspection ran Dec 14 – Dec 19, 2023, and the Form 483 is dated December 19, 2023.
How do I get the full Form 483 for Xiamen Tiger Medical Company, Ltd.?
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