Palisades Compounding Pharmacy
Form 483 issued March 15, 2023 · Pacific Palisades, California
- Inspection
- Feb 23 – Mar 15, 2023
- Investigator
- Darren S. Brown
- Observations
- 2
- Pages
- 3
- FEI number
- 3008174851
In short: On March 15, 2023, FDA issued a Form 483 with 2 observations to Palisades Compounding Pharmacy in Pacific Palisades, California (FEI 3008174851) after an inspection that ran Feb 23 – Mar 15, 2023. The investigator was Darren S. Brown. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 1 system, led by materials.
Most cited: FDCA 501(a)(2)(A) (1×) · 211.84 (1×)
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 drngs without providing adequate segregation, cleaning of work surfaces and cleaning of…
- 02
Your fnm released diug product in which the strength differs from, or its purity or quality…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPalisades 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Palisades Compounding Pharmacy?
FDA listed 2 observations on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Palisades Compounding Pharmacy?
Darren S. Brown is named on this Form 483, for the inspection of Feb 23 – Mar 15, 2023. Each investigator has a profile showing what they cite most.
When was Palisades Compounding Pharmacy inspected by FDA?
The inspection ran Feb 23 – Mar 15, 2023, and the Form 483 is dated March 15, 2023.
How do I get the full Form 483 for Palisades Compounding Pharmacy?
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