Bloomage Biotechnology corp., Ltd.
Form 483 issued April 26, 2019 · Jinan, China
- Inspection
- Apr 22 – Apr 26, 2019
- Investigator
- Launmer Ulgn-Tomes
- Observations
- 4
- Pages
- 4
- FEI number
- 3008240723
In short: On April 26, 2019, FDA issued a Form 483 with 4 observations to Bloomage Biotechnology corp., Ltd. in Jinan, Shandong (FEI 3008240723) after an inspection that ran Apr 22 – Apr 26, 2019. The investigator was Launmer Ulgn-Tomes. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
3 of 4 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (3×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities of the quality unit are not follow. Your quality unit fails to properly review…
- 02
Validated analytical methods are…
- 03
Laboratory records do not include complete records of the periodic…
- 04
For each batch of raw material, intermediate and API, appropriate laboratory tests were not conducted to…
This inspection in context
Launmer Ulgn-Tomes
1 document · 2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmBloomage Biotechnology corp., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bloomage Biotechnology corp., Ltd.?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Bloomage Biotechnology corp., Ltd.?
Launmer Ulgn-Tomes is named on this Form 483, for the inspection of Apr 22 – Apr 26, 2019. Each investigator has a profile showing what they cite most.
When was Bloomage Biotechnology corp., Ltd. inspected by FDA?
The inspection ran Apr 22 – Apr 26, 2019, and the Form 483 is dated April 26, 2019.
How do I get the full Form 483 for Bloomage Biotechnology corp., Ltd.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.