Form 483 · FEI 3004575449
Form 483 issued January 16, 2023 · San Diego, California
- Inspection
- Jan 11 – Jan 16, 2023
- Investigators
- Christopher R. Czajka· Michael R. Shanks· Yi Wang
- Observations
- 3
- Pages
- 2
- FEI number
- 3004575449
In short: On January 16, 2023, FDA issued a Form 483 with 3 observations to an FDA-inspected site in San Diego, California (FEI 3004575449) after an inspection that ran Jan 11 – Jan 16, 2023. The investigators were Christopher R. Czajka, Michael R. Shanks and Yi Wang. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality oversight of validation…
- 02
Facility and Equipment maintenance are deficient in their ability to…
- 03
The responsibilities and procedures applicable to the quality control unit…
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 firmSite history
All 13 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Christopher R. Czajka, Michael R. Shanks and Yi Wang are named on this Form 483, for the inspection of Jan 11 – Jan 16, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 11 – Jan 16, 2023, and the Form 483 is dated January 16, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.