Yuhan Chemical, Inc.
Form 483 issued September 22, 2017 · Ansan-si, South Korea
- Observations
- 6
- Pages
- 5
- FEI number
- 3004015296
In short: On September 22, 2017, FDA issued a Form 483 with 6 observations to Yuhan Chemical, Inc. in Ansan-si, Gyeonggi-do (FEI 3004015296). 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 6 observations.
Most cited: 21 CFR 211.67 (2×)
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 and…
- 02
Lots of intermediate material that failed to meet Out-of-trend (OOT) specifications were not reprocessed prior to…
- 03
Failure to establish total number of batches…
- 04
Appropriate control is not established over computerized…
This inspection in context
Questions about this 483
What did FDA find at Yuhan Chemical, Inc.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. 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 Yuhan Chemical, Inc. inspected by FDA?
This Form 483 is dated September 22, 2017.
How do I get the full Form 483 for Yuhan Chemical, Inc.?
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.