Leiter's Compounding Pharmacy
Form 483 issued November 17, 2023 · San Jose, California
- Inspection
- Nov 1 – Nov 17, 2023
- Investigators
- Andrew Le· Anney Lin· Jeffrey P. Raimondi
- Observations
- 8
- Pages
- 9
- FEI number
- 3003434972
In short: On November 17, 2023, FDA issued a Form 483 with 8 observations to Leiter's Compounding Pharmacy in San Jose, California (FEI 3003434972) after an inspection that ran Nov 1 – Nov 17, 2023. The investigators were Andrew Le, Anney Lin and Jeffrey P. Raimondi. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records are not always made of…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmLeiter's Compounding Pharmacy history
All 15 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Leiter's Compounding Pharmacy?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Leiter's Compounding Pharmacy?
Andrew Le, Anney Lin and Jeffrey P. Raimondi are named on this Form 483, for the inspection of Nov 1 – Nov 17, 2023. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Nov 1 – Nov 17, 2023, and the Form 483 is dated November 17, 2023.
How do I get the full Form 483 for Leiter's Compounding Pharmacy?
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