Hanlim Pharm. Co., Ltd.
Form 483 issued May 31, 2022 · Yongin-si, South Korea
- Inspection
- May 23 – May 31, 2022
- Investigator
- Truong X. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3004886113
In short: On May 31, 2022, FDA issued a Form 483 with 2 observations to Hanlim Pharm. Co., Ltd. in Yongin-si, Gyeonggi-do (FEI 3004886113) after an inspection that ran May 23 – May 31, 2022. The investigator was Truong X. Nguyen. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (2×) · 21 CFR 11 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Input to and output from the computer and records or data are…
- 0221 CFR 211.68(b)21 CFR 11
Failure to maintain a backup file of data entered into the computer or related system. Electronic…
This inspection in context
Truong X. Nguyen
20 documents · 2011–2026
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmHanlim Pharm. Co., Ltd. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hanlim Pharm. Co., Ltd.?
FDA listed 2 observations on this Form 483, mostly about 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.
Who inspected Hanlim Pharm. Co., Ltd.?
Truong X. Nguyen is named on this Form 483, for the inspection of May 23 – May 31, 2022. Each investigator has a profile showing what they cite most.
When was Hanlim Pharm. Co., Ltd. inspected by FDA?
The inspection ran May 23 – May 31, 2022, and the Form 483 is dated May 31, 2022.
How do I get the full Form 483 for Hanlim Pharm. 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.