JO Cosmetics Co., Ltd.
Form 483 issued October 24, 2018 · Hanyu, Japan
- Inspection
- Oct 22 – Oct 24, 2018
- Investigator
- Niketa Patel
- Observations
- 4
- Pages
- 3
- FEI number
- 3006477904
In short: On October 24, 2018, FDA issued a Form 483 with 4 observations to JO Cosmetics Co., Ltd. in Hanyu, Saitama (FEI 3006477904) after an inspection that ran Oct 22 – Oct 24, 2018. The investigator was Niketa Patel. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 3 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
Employees are not given training in…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Observation 3: scanned text, readable in the full document.
- 04
quality and…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmJO Cosmetics Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at JO Cosmetics Co., Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected JO Cosmetics Co., Ltd.?
Niketa Patel is named on this Form 483, for the inspection of Oct 22 – Oct 24, 2018. Each investigator has a profile showing what they cite most.
When was JO Cosmetics Co., Ltd. inspected by FDA?
The inspection ran Oct 22 – Oct 24, 2018, and the Form 483 is dated October 24, 2018.
How do I get the full Form 483 for JO Cosmetics 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.