HK INNO.N CORPORATION
Form 483 issued January 24, 2025 · Heungbeok Cheongju, South Korea
- Inspection
- Jan 16 – Jan 24, 2025
- Observations
- 11
- Pages
- 15
- FEI number
- 3022306074
In short: On January 24, 2025, FDA issued a Form 483 with 11 observations to HK INNO.N CORPORATION in Heungbeok Cheongju, Chungcheongbuk (FEI 3022306074) after an inspection that ran Jan 16 – Jan 24, 2025. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.113 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Written specifications for laboratory controls do not include a description of…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Questions about this 483
What did FDA find at HK INNO.N CORPORATION?
FDA listed 11 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
When was HK INNO.N CORPORATION inspected by FDA?
The inspection ran Jan 16 – Jan 24, 2025, and the Form 483 is dated January 24, 2025.
How do I get the full Form 483 for HK INNO.N CORPORATION?
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.