CEB Michigan Inc
Form 483 issued October 17, 2024 · Edwardsburg, Michigan
- Inspection
- Oct 16 – Oct 17, 2024
- Investigators
- Anna M. Spiros· Jacob G. Lutz
- Observations
- 4
- Pages
- 5
- FEI number
- 3011901066
In short: On October 17, 2024, FDA issued a Form 483 with 4 observations to CEB Michigan Inc in Edwardsburg, Michigan (FEI 3011901066) after an inspection that ran Oct 16 – Oct 17, 2024. The investigators were Anna M. Spiros and Jacob G. Lutz. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
Testing and release of ding product for distribution do not include appropriate laboratory determination of satisfactoiy…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Anna M. Spiros
6 documents · 2024–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Michigan.
The firmCEB Michigan Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CEB Michigan Inc?
FDA listed 4 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected CEB Michigan Inc?
Anna M. Spiros and Jacob G. Lutz are named on this Form 483, for the inspection of Oct 16 – Oct 17, 2024. Each investigator has a profile showing what they cite most.
When was CEB Michigan Inc inspected by FDA?
The inspection ran Oct 16 – Oct 17, 2024, and the Form 483 is dated October 17, 2024.
How do I get the full Form 483 for CEB Michigan 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.