ClinImmune Labs
Form 483 issued July 19, 2019 · Aurora, Colorado
- Inspection
- Jul 10 – Jul 19, 2019
- Investigators
- Amy A. Johnson· Wcstbce Cynthia Jim
- Observations
- 7
- Pages
- 6
- FEI number
- 3000719146
In short: On July 19, 2019, FDA issued a Form 483 with 7 observations to ClinImmune Labs in Aurora, Colorado (FEI 3000719146) after an inspection that ran Jul 10 – Jul 19, 2019. The investigators were Amy A. Johnson and Wcstbce Cynthia Jim. Most observations concern quality system and facilities & equipment.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Training is not conducted with sufficient frequency to assure that employees remain familiar with gowning…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
All records pertinent to a lot or unit were not reviewed before the release or distribution…
This inspection in context
Amy A. Johnson
3 documents · 2019–2025
Cites 606.100(b) (standard operating procedures) more than any other section. Most of their documents are for sites in California.
The firmClinImmune Labs history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ClinImmune Labs?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected ClinImmune Labs?
Amy A. Johnson and Wcstbce Cynthia Jim are named on this Form 483, for the inspection of Jul 10 – Jul 19, 2019. Each investigator has a profile showing what they cite most.
When was ClinImmune Labs inspected by FDA?
The inspection ran Jul 10 – Jul 19, 2019, and the Form 483 is dated July 19, 2019.
How do I get the full Form 483 for ClinImmune Labs?
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.