RC Outsourcing, LLC
FDA 503B outsourcing facility
Lowellville, Ohio
Key Takeaways
- FDA-registered 503B outsourcing facility since 2015
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: August 28, 2025
- FDA action: Warning Letter Issued 3/20/2026
- 1 FDA drug recall on record (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
- October 7, 2015
- Most recent registration
- November 27, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- August 28, 2025
The FDA last inspected RC Outsourcing, LLC on August 28, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Warning Letter Issued 3/20/2026.
FDA recall history
RC Outsourcing, LLC has 1 FDA drug recall on record in 2025, based on the FDA enforcement database. Breakdown: 1 Class II.
Recall reasons on record include lack of assurance of sterility.
| Date | Class | Product | Reason |
|---|---|---|---|
| September 2025 | Class II | Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume, Rx Only, Hospital/Office Use Only, Refrigerate, RC Outsou | Lack of assurance of sterility. |
FDA recall classes signal severity, not intent: Class I means a reasonable probability of serious harm, Class II a temporary or reversible risk, Class III a violation unlikely to cause harm. Sterile compounders routinely recall lots as a precaution. FDA definitions.
Compounded peptides and GLP-1s
RC Outsourcing, LLC has not assigned NDCs or filed product reports in the most recent FDA reporting periods. 503B outsourcing facilities are a primary supply route for compounded peptides and GLP-1s during FDA-listed shortages; PeptideGrids grades the evidence for each, including Semaglutide, Tirzepatide, BPC-157, Retatrutide. Browse the GLP-1 and therapeutic peptide databases.
Location
102 E Water St, Lowellville, OH 44436-1117
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Contact
FDA-registered contact: Michael Basista, 330-536-8500. 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 RC Outsourcing, LLC with the State of Ohio Board of Pharmacy.
503B facilities in Ohio
Ohio has 3 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Ohio.
Frequently asked questions
Is RC Outsourcing, LLC registered with the FDA?
Yes. RC Outsourcing, LLC is a registered 503B outsourcing facility, first registered with the FDA on October 7, 2015 and most recently registered on November 27, 2025.
Has RC Outsourcing, LLC been inspected by the FDA?
The FDA last inspected RC Outsourcing, LLC on August 28, 2025. A Form FDA 483 was issued. FDA action on record: Warning Letter Issued 3/20/2026.
Has RC Outsourcing, LLC had any FDA drug recalls?
RC Outsourcing, LLC has 1 FDA drug recall on record (2025) in the FDA enforcement database.
What does RC Outsourcing, LLC compound?
RC Outsourcing, LLC has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is RC Outsourcing, LLC located?
RC Outsourcing, LLC is located in Lowellville, Ohio (102 E Water St).
Registration and inspection data verified against the FDA list of registered outsourcing facilities on June 6, 2026. Recall history from the FDA openFDA drug enforcement database, retrieved June 6, 2026.
PeptideGrids is independent and not affiliated with, endorsed by, or sponsored by RC Outsourcing, LLC. 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.