Jilin Asymchem Laboratories Co., Ltd.
Form 483 issued April 12, 2019 · Dunhua, China
- Inspection
- Apr 8 – Apr 12, 2019
- Investigator
- Christopher Keating
- Observations
- 4
- Pages
- 4
- FEI number
- 3010165374
In short: On April 12, 2019, FDA issued a Form 483 with 4 observations to Jilin Asymchem Laboratories Co., Ltd. in Dunhua, Jilin (FEI 3010165374) after an inspection that ran Apr 8 – Apr 12, 2019. The investigator was Christopher Keating. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspections into adequacy of laboratory equipment qualifications and software validations, including assessment of preventative…
- 02
Your design and execution of cleaning validation protocols are not adequate and risk assessments do not…
- 03
Laboratory investigations are not…
- 04
Records were not made readily…
This inspection in context
Christopher Keating
13 documents · 2018–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJilin Asymchem Laboratories Co., Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jilin Asymchem Laboratories Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Jilin Asymchem Laboratories Co., Ltd.?
Christopher Keating is named on this Form 483, for the inspection of Apr 8 – Apr 12, 2019. Each investigator has a profile showing what they cite most.
When was Jilin Asymchem Laboratories Co., Ltd. inspected by FDA?
The inspection ran Apr 8 – Apr 12, 2019, and the Form 483 is dated April 12, 2019.
How do I get the full Form 483 for Jilin Asymchem Laboratories 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.