SEL Biochem Xinjiang Co., Ltd.
Form 483 issued March 29, 2019 · Shihezi City, China
- Inspection
- Mar 25 – Mar 29, 2019
- Investigator
- Liming Zhang
- Observations
- 4
- Pages
- 2
- FEI number
- 3010468390
In short: On March 29, 2019, FDA issued a Form 483 with 4 observations to SEL Biochem Xinjiang Co., Ltd. in Shihezi City, China (FEI 3010468390) after an inspection that ran Mar 25 – Mar 29, 2019. The investigator was Liming Zhang. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and laboratory controls account for 4 of 4 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing equipment cleaning procedures and the…
- 02
The toilets and gowning room inside the workshop ™ and workshop” were not equipped with hot…
- 03
The equipment to measure for API manufacturing in-process control samples…
- 04
Test procedures used to analyze! API…
This inspection in context
Liming Zhang
19 documents · 2014–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmSEL Biochem Xinjiang Co., 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 SEL Biochem Xinjiang Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected SEL Biochem Xinjiang Co., Ltd.?
Liming Zhang is named on this Form 483, for the inspection of Mar 25 – Mar 29, 2019. Each investigator has a profile showing what they cite most.
When was SEL Biochem Xinjiang Co., Ltd. inspected by FDA?
The inspection ran Mar 25 – Mar 29, 2019, and the Form 483 is dated March 29, 2019.
How do I get the full Form 483 for SEL Biochem Xinjiang Co., 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.