CIS Bio International
Form 483 issued December 16, 2022 · Gif sur Yvette, France
- Inspection
- Dec 8 – Dec 16, 2022
- Investigator
- Nancy M. Espinal
- Observations
- 8
- Pages
- 6
- FEI number
- 1000268008
In short: On December 16, 2022, FDA issued a Form 483 with 8 observations to CIS Bio International in Gif sur Yvette, Ile-de-France (FEI 1000268008) after an inspection that ran Dec 8 – Dec 16, 2022. The investigator was Nancy M. Espinal. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established quality control…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Written procedures are not established for evaluations conducted at least annually to review records associated with…
- 04
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmCIS Bio International history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CIS Bio International?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected CIS Bio International?
Nancy M. Espinal is named on this Form 483, for the inspection of Dec 8 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was CIS Bio International inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
How do I get the full Form 483 for CIS Bio International?
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.