Lynn Oaks Compounding Pharmacy
Form 483 issued April 15, 2022 · California
- Inspection
- Apr 5 – Apr 15, 2022
- Investigators
- James B. Arnett· Taichun Qin
- Observations
- 7
- Pages
- 6
- FEI number
- 3021028639
In short: On April 15, 2022, FDA issued a Form 483 with 7 observations to Lynn Oaks Compounding Pharmacy in California (FEI 3021028639) after an inspection that ran Apr 5 – Apr 15, 2022. The investigators were James B. Arnett and Taichun Qin. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Observations span 1 system, led by laboratory controls.
Most cited: FDCA 501(a)(2)(A) (3×)
What FDA observed
Preview: the opening words of each observation- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate containment, cleaning of work surfaces and cleaning of…
- 02FDCA 501(a)(2)(A)
You used a non-pharmaceutical grade component in the formulation…
- 03FDCA 501(a)(2)(A)
Vermin was observed in…
- 04
Each batch of drug product required to be free of objectionable microorganisms is not tested…
This inspection in context
James B. Arnett
2 documents · 2021–2022
Cites 211.166(a) (stability testing) more than any other section. Most of their documents are for sites in Arizona.
The firmLynn Oaks 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lynn Oaks Compounding Pharmacy?
FDA listed 7 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Lynn Oaks Compounding Pharmacy?
James B. Arnett and Taichun Qin are named on this Form 483, for the inspection of Apr 5 – Apr 15, 2022. Each investigator has a profile showing what they cite most.
When was Lynn Oaks Compounding Pharmacy inspected by FDA?
The inspection ran Apr 5 – Apr 15, 2022, and the Form 483 is dated April 15, 2022.
How do I get the full Form 483 for Lynn Oaks 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.