Dongying Tiandong Pharmaceutical Co.,Ltd
Form 483 issued October 19, 2018 · Dongying, China
- Inspection
- Oct 15 – Oct 19, 2018
- Investigator
- Marijo B. Kambere
- Observations
- 2
- Pages
- 2
- FEI number
- 3004395180
In short: On October 19, 2018, FDA issued a Form 483 with 2 observations to Dongying Tiandong Pharmaceutical Co.,Ltd in Dongying, Shandong (FEI 3004395180) after an inspection that ran Oct 15 – Oct 19, 2018. The investigator was Marijo B. Kambere. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documentation and records are…
- 02
Laboratory control records are…
This inspection in context
Marijo B. Kambere
11 documents · 2015–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmDongying Tiandong Pharmaceutical Co.,Ltd history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dongying Tiandong Pharmaceutical Co.,Ltd?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected Dongying Tiandong Pharmaceutical Co.,Ltd?
Marijo B. Kambere is named on this Form 483, for the inspection of Oct 15 – Oct 19, 2018. Each investigator has a profile showing what they cite most.
When was Dongying Tiandong Pharmaceutical Co.,Ltd inspected by FDA?
The inspection ran Oct 15 – Oct 19, 2018, and the Form 483 is dated October 19, 2018.
How do I get the full Form 483 for Dongying Tiandong Pharmaceutical Co.,Ltd?
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