JO Cosmetics Co., Ltd.
Form 483 issued May 22, 2025 · Hanyu, Japan
- Inspection
- May 19 – May 22, 2025
- Observations
- 4
- Pages
- 3
- FEI number
- 3006477904
In short: On May 22, 2025, FDA issued a Form 483 with 4 observations to JO Cosmetics Co., Ltd. in Hanyu, Saitama (FEI 3006477904) after an inspection that ran May 19 – May 22, 2025. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
This inspection in context
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, production and facilities & equipment. 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.
When was JO Cosmetics Co., Ltd. inspected by FDA?
The inspection ran May 19 – May 22, 2025, and the Form 483 is dated May 22, 2025.
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.