Aqualex Co., Ltd.
FDA inspection history in Seongnam-si, South Korea, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Seongnam-si, South Korea.
Cited most
Across all Aqualex Co. observations on file
- 21 CFR 211.160(a)General requirements2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.63Equipment design, size, and location1
The complete Aqualex Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Seongnam-si, South Korea
One Form 483 · 2023 · 6 observations
Latest: Form 483, Oct 20, 2023 →
Also: one document not tied to a site.
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-12 | Warning letter Warning letter | — | — | $99 |
| 2023-10-20 | 483 Form 483 | Seongnam-si, South Korea | 6 | $99 |
Investigators on these documents
FEI number 3010683345 · most recent document Jun 12, 2024
About Aqualex Co., Ltd.
How many FDA Form 483s has Aqualex Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Aqualex Co., Ltd.; the most recent is dated Oct 20, 2023.
When was Aqualex Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Aqualex Co., Ltd. is a Form 483 dated Oct 20, 2023, for the site in Seongnam-si, South Korea.
What did FDA cite at Aqualex Co., Ltd.?
The regulations cited most in the observations on file for Aqualex Co., Ltd. are 21 CFR 211.160(a) (General requirements), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Aqualex Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Aqualex Co., Ltd.; the most recent is dated Jun 12, 2024.