CELLTRION PHARM, INC
Form 483 issued September 14, 2023 · Cheongju, South Korea
- Investigator
- John A. Sciacchitano
- Observations
- 3
- Pages
- 45
- FEI number
- 3012279978
In short: On September 14, 2023, FDA issued a Form 483 with 3 observations to CELLTRION PHARM, INC in Cheongju, Chungcheongbuk-do (FEI 3012279978). The investigator was John A. Sciacchitano. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.52 (if I am a manufacturer, what information must I submit in my individual adverse event reports?).
At a glance
3 of 3 observations on this 483 concern capa.
Most cited: 21 CFR 803.52 (2×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
An individual medical device manufacturer report submitted per Form FDA 3500A format did not indicate in…
- 03
An individual medical device manufacturer report submitted per Form FDA 3500A format did not contain in…
This inspection in context
John A. Sciacchitano
2 documents · 2022–2023
Cites 803.52 (if i am a manufacturer, what information must i submit in my individual adverse event reports?) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCELLTRION PHARM, INC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.52
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CELLTRION PHARM, INC?
FDA listed 3 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.52 (if I am a manufacturer, what information must I submit in my individual adverse event reports?). The opening words of each observation are shown on this page.
Who inspected CELLTRION PHARM, INC?
John A. Sciacchitano is named on this Form 483. Each investigator has a profile showing what they cite most.
When was CELLTRION PHARM, INC inspected by FDA?
This Form 483 is dated September 14, 2023.
How do I get the full Form 483 for CELLTRION PHARM, INC?
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.