CELLTRION Inc
Form 483 issued July 17, 2018
- Observations
- 8
- Pages
- 4
- FEI number
- 3005241015
In short: On July 17, 2018, FDA issued a Form 483 with 8 observations to CELLTRION Inc (FEI 3005241015).
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Employees engaged in the processing of a drug product lack the training required to…
- 03
Routine checking of automatic equipment is not performed according to a written procedure designed…
- 04
Procedures describing the calibration of instruments, apparatus, gauges, and recording devices are…
This inspection in context
Questions about this 483
What did FDA find at CELLTRION Inc?
FDA listed 8 observations on this Form 483. The opening words of each observation are shown on this page.
When was CELLTRION Inc inspected by FDA?
This Form 483 is dated July 17, 2018.
How do I get the full Form 483 for CELLTRION 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.