Sanitor Corporation
Form 483 issued April 14, 2023 · Stanton, California
- Inspection
- Apr 14, 2023
- Investigator
- Christopher R. Czajka
- Observations
- 5
- Pages
- 7
- FEI number
- 3005871025
In short: On April 14, 2023, FDA issued a Form 483 with 5 observations to Sanitor Corporation in Stanton, California (FEI 3005871025) after an inspection that ran Apr 14, 2023. The investigator was Christopher R. Czajka. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Employees are not given training in the particular operations they perform as part of their function…
- 04
Results of stability testing are not used in…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmSanitor Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
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 Sanitor Corporation?
FDA listed 5 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 Sanitor Corporation?
Christopher R. Czajka is named on this Form 483, for the inspection of Apr 14, 2023. Each investigator has a profile showing what they cite most.
When was Sanitor Corporation inspected by FDA?
The inspection ran Apr 14, 2023, and the Form 483 is dated April 14, 2023.
How do I get the full Form 483 for Sanitor 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.