Wedgewood Connect, LLC, formerly registered as Leiter's Compounding
FDA 503B outsourcing facility
San Jose, California
Key Takeaways
- FDA-registered 503B outsourcing facility since 2014
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: July 3, 2025
About this facility
A 503B outsourcing facility is registered with the FDA under the Drug Quality and Security Act and may compound sterile medications in bulk without patient-specific prescriptions, under cGMP manufacturing standards. How federal compounding status works.
FDA registration and inspection record
- First registered with FDA
- January 31, 2014
- Most recent registration
- November 25, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- July 3, 2025
The FDA last inspected Wedgewood Connect, LLC, formerly registered as Leiter's Compounding on July 3, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
What this facility compounds
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding reports compounding 1 distinct active ingredient to the FDA Outsourcing Facility Product Report (most recent reporting periods).
- Moxifloxacin Hydrochloride
Contact
FDA-registered contact: Paul Yamamoto, 669-297-0857. Source: the facility's FDA outsourcing registration.
License verification
503B outsourcing facilities are also licensed by the state board of pharmacy. Verify the current license status of Wedgewood Connect, LLC, formerly registered as Leiter's Compounding with the California State Board of Pharmacy.
503B facilities in California
California has 7 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in California.
Frequently asked questions
Is Wedgewood Connect, LLC, formerly registered as Leiter's Compounding registered with the FDA?
Yes. Wedgewood Connect, LLC, formerly registered as Leiter's Compounding is a registered 503B outsourcing facility, first registered with the FDA on January 31, 2014 and most recently registered on November 25, 2025.
Has Wedgewood Connect, LLC, formerly registered as Leiter's Compounding been inspected by the FDA?
The FDA last inspected Wedgewood Connect, LLC, formerly registered as Leiter's Compounding on July 3, 2025. A Form FDA 483 was issued.
Has Wedgewood Connect, LLC, formerly registered as Leiter's Compounding had any FDA drug recalls?
No FDA drug recalls are matched to Wedgewood Connect, LLC, formerly registered as Leiter's Compounding in the openFDA enforcement database.
What does Wedgewood Connect, LLC, formerly registered as Leiter's Compounding compound?
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding reports compounding 1 active ingredient to the FDA.
Where is Wedgewood Connect, LLC, formerly registered as Leiter's Compounding located?
Wedgewood Connect, LLC, formerly registered as Leiter's Compounding is located in San Jose, California.
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by Wedgewood Connect, LLC, formerly registered as Leiter's Compounding. Listings, registration, inspection, and recall data are reported from public FDA records for informational purposes only. A recall or inspection finding is not an accusation of current wrongdoing. This is not medical or legal advice. To request a correction, see our corrections policy.