Aqualex Co., Ltd.

Form 483 issued October 20, 2023 · Seongnam-si, South Korea

Inspection: Oct 16 – Oct 20, 2023
Investigator: Wayne D. McGrath
Observations: 6
Pages: 4
FEI number: 3010683345

In short: On October 20, 2023, FDA issued a Form 483 with 6 observations to Aqualex Co., Ltd. in Seongnam-si, Gyeonggi - do (FEI 3010683345) after an inspection that ran Oct 16 – Oct 20, 2023. The investigator was Wayne D. McGrath. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).

At a glance

Laboratory controls and quality system account for 4 of 6 observations.

Laboratory controls3

Quality system1

Production1

Facilities & equipment1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

01
21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in…
02
21 CFR 211.166(a)
There is no written testing program designed to assess the stability…
03
21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
04
21 CFR 211.113 21 CFR 211.63
Observation 4: scanned text, readable in the full document.

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Wayne D. McGrath

33 documents · 2018–2025

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.

The firm

Aqualex Co., Ltd. history

All 2 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.22(d)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Aqualex Co., Ltd.?

FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.

Who inspected Aqualex Co., Ltd.?

Wayne D. McGrath is named on this Form 483, for the inspection of Oct 16 – Oct 20, 2023. Each investigator has a profile showing what they cite most.

When was Aqualex Co., Ltd. inspected by FDA?

The inspection ran Oct 16 – Oct 20, 2023, and the Form 483 is dated October 20, 2023.

How do I get the full Form 483 for Aqualex 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.