CELLTRION PHARM, INC
Form 483 issued July 23, 2024 · Cheongju, South Korea
- Observations
- 3
- Pages
- 3
- FEI number
- 3012279978
In short: On July 23, 2024, FDA issued a Form 483 with 3 observations to CELLTRION PHARM, INC in Cheongju, Chungcheongbuk-do (FEI 3012279978). Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
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 are not…
- 02
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at CELLTRION PHARM, INC?
FDA listed 3 observations on this Form 483, mostly about quality system and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was CELLTRION PHARM, INC inspected by FDA?
This Form 483 is dated July 23, 2024.
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.