FNC MEDICAL CORPORATION
Form 483 issued December 9, 2022 · VENTURA, California
- Investigator
- Claudia M. Perez-Kasmarski
- Observations
- 4
- Pages
- 4
- FEI number
- 1000160563
In short: On December 9, 2022, FDA issued a Form 483 with 4 observations to FNC MEDICAL CORPORATION in VENTURA, California (FEI 1000160563). The investigator was Claudia M. Perez-Kasmarski. Most observations concern laboratory controls and quality system.
At a glance
3 of 4 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The accuracy and reproducibility of test methods have not…
- 03
Established laboratory control mechanisms are not documented at…
- 04
Laboratory records are deficient in that they do not include the initials of thelf/{{(6)(@)Ill) reviewing…
This inspection in context
Claudia M. Perez-Kasmarski
11 documents · 2020–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmFNC MEDICAL CORPORATION history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at FNC MEDICAL CORPORATION?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected FNC MEDICAL CORPORATION?
Claudia M. Perez-Kasmarski is named on this Form 483. Each investigator has a profile showing what they cite most.
When was FNC MEDICAL CORPORATION inspected by FDA?
This Form 483 is dated December 9, 2022.
How do I get the full Form 483 for FNC MEDICAL CORPORATION?
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.