Hanlim Pharm. Co., Ltd.
Form 483 issued February 6, 2018 · Yonginsi Ceoin-gu, South Korea
- Inspection
- Jan 29 – Feb 6, 2018
- Investigator
- Rachel C. Harrington
- Observations
- 7
- Pages
- 8
- FEI number
- 3004886113
In short: On February 6, 2018, FDA issued a Form 483 with 7 observations to Hanlim Pharm. Co., Ltd. in Yonginsi Ceoin-gu, South Korea (FEI 3004886113) after an inspection that ran Jan 29 – Feb 6, 2018. The investigator was Rachel C. Harrington. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
- 04
Established test procedures are not documented at…
This inspection in context
Rachel C. Harrington
7 documents · 2012–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Maryland.
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 211.113(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 7 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Hanlim Pharm. Co., Ltd.?
Rachel C. Harrington is named on this Form 483, for the inspection of Jan 29 – Feb 6, 2018. Each investigator has a profile showing what they cite most.
When was Hanlim Pharm. Co., Ltd. inspected by FDA?
The inspection ran Jan 29 – Feb 6, 2018, and the Form 483 is dated February 6, 2018.
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.