California Specialty Pharmacy Inc.
Form 483 issued May 17, 2019 · Whittier, California
- Inspection
- May 13 – May 17, 2019
- Investigator
- Stephanie A. Slater
- Observations
- 2
- Pages
- 2
- FEI number
- 3015131323
In short: On May 17, 2019, FDA issued a Form 483 with 2 observations to California Specialty Pharmacy Inc. in Whittier, California (FEI 3015131323) after an inspection that ran May 13 – May 17, 2019. The investigator was Stephanie A. Slater. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.84 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You used a non-pharmaceutical grade component in the formulation…
- 02
You produced hazardous drugs without providing adequate cleaning of work surfaces and cleaning of…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmCalifornia Specialty Pharmacy Inc. 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 California Specialty Pharmacy Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. 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 California Specialty Pharmacy Inc.?
Stephanie A. Slater is named on this Form 483, for the inspection of May 13 – May 17, 2019. Each investigator has a profile showing what they cite most.
When was California Specialty Pharmacy Inc. inspected by FDA?
The inspection ran May 13 – May 17, 2019, and the Form 483 is dated May 17, 2019.
How do I get the full Form 483 for California Specialty Pharmacy Inc.?
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.