Leiter's Compounding Pharmacy
Amended 483 issued July 3, 2025 · San Jose, California
- Inspection
- Jun 23 – Jul 3, 2025
- Investigators
- Jolanna A. Norton· Matthew R. Clabeaux
- Observations
- 3
- Pages
- 5
- FEI number
- 3003434972
In short: On July 3, 2025, FDA issued a Amended 483 with 3 observations to Leiter's Compounding Pharmacy in San Jose, California (FEI 3003434972) after an inspection that ran Jun 23 – Jul 3, 2025. The investigators were Jolanna A. Norton and Matthew R. Clabeaux. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Employees are not given training in the particular operations they perform as…
- 03
Aseptic processing areas are deficient regarding the system…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 documentsOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at Leiter's Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Leiter's Compounding Pharmacy?
Jolanna A. Norton and Matthew R. Clabeaux are named on this Amended 483, for the inspection of Jun 23 – Jul 3, 2025. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Jun 23 – Jul 3, 2025, and the Amended 483 is dated July 3, 2025.
How do I get the full Amended 483 for Leiter's 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.