Expert Compounding Pharmacy
Form 483 issued March 4, 2022 · Lake Bal boa, California
- Inspection
- Feb 23 – Mar 4, 2022
- Investigator
- Christopher R. Czajka
- Observations
- 6
- Pages
- 5
- FEI number
- 3010681729
In short: On March 4, 2022, FDA issued a Form 483 with 6 observations to Expert Compounding Pharmacy in Lake Bal boa, California (FEI 3010681729) after an inspection that ran Feb 23 – Mar 4, 2022. The investigator was Christopher R. Czajka. Most observations concern laboratory controls and production.
At a glance
Observations span 2 systems, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without prov iding adequate cleaning of utensils to…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
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 firmExpert Compounding Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Expert Compounding Pharmacy?
FDA listed 6 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Expert Compounding Pharmacy?
Christopher R. Czajka is named on this Form 483, for the inspection of Feb 23 – Mar 4, 2022. Each investigator has a profile showing what they cite most.
When was Expert Compounding Pharmacy inspected by FDA?
The inspection ran Feb 23 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Expert Compounding Pharmacy?
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.