CSL Behring AG
Form 483 issued February 18, 2020 · Bern, Switzerland
- Inspection
- Feb 10 – Feb 18, 2020
- Investigators
- Nimmy Mathews· Prabhu P. Raju
- Observations
- 4
- Pages
- 5
- FEI number
- 3002806716
In short: On February 18, 2020, FDA issued a Form 483 with 4 observations to CSL Behring AG in Bern, Switzerland (FEI 3002806716) after an inspection that ran Feb 10 – Feb 18, 2020. The investigators were Nimmy Mathews and Prabhu P. Raju. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 02
Appropriate written procedures, designed to prevent microbiological contamination of drug products purporting to be sterile, were…
- 03
Electronic production and laboratory blank fonns/worksheets u:;cd were not adequately controlled b) the quality control unit…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Nimmy Mathews
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmCSL Behring AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CSL Behring AG?
FDA listed 4 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected CSL Behring AG?
Nimmy Mathews and Prabhu P. Raju are named on this Form 483, for the inspection of Feb 10 – Feb 18, 2020. Each investigator has a profile showing what they cite most.
When was CSL Behring AG inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2020, and the Form 483 is dated February 18, 2020.
How do I get the full Form 483 for CSL Behring AG?
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.