Park Avenue Compounding
FDA 503B outsourcing facility
St. Louis, Missouri
Key Takeaways
- FDA-registered 503B outsourcing facility since 2023
- Sterile compounding from bulk substances: No
- Last FDA inspection: September 23, 2025
- FDA action: Regulatory Meeting Held 5/7/2026
- 2 FDA drug recalls 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
- December 23, 2023
- Most recent registration
- November 19, 2025
- Compounds sterile drugs from bulk substances
- No
- Last FDA inspection
- September 23, 2025
The FDA last inspected Park Avenue Compounding on September 23, 2025. Investigators issued a Form FDA 483 listing inspectional observations at that visit. FDA action on record: Regulatory Meeting Held 5/7/2026.
FDA recall history
Park Avenue Compounding has 2 FDA drug recalls on record in 2025, based on the FDA enforcement database. Breakdown: 2 Class II.
Recall reasons on record include cgmp deviations: revised interpretation of acceptable quality level (aql) results; cgmp deviations.
| Date | Class | Product | Reason |
|---|---|---|---|
| September 2025 | Class II | Fentanyl citrate, 2 mcg / ml / Ropivacaine, 0.2% in NS 150 mL, CII, 150 mL bag, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Loui | CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results. |
| September 2025 | Class II | Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only, Park Avenue Compounding, 3662 Park Ave, Saint Louis, MO, 63110-2512, NDC 8 | CGMP Deviations |
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
Park Avenue Compounding 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
3662 Park Ave Ste 140, Saint Louis, MO 63110-2512
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Contact
FDA-registered contact: Steven Garhartt, 603-953-6675. 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 Park Avenue Compounding with the Missouri Board of Pharmacy.
503B facilities in Missouri
Missouri has 3 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Missouri.
Frequently asked questions
Is Park Avenue Compounding registered with the FDA?
Yes. Park Avenue Compounding is a registered 503B outsourcing facility, first registered with the FDA on December 23, 2023 and most recently registered on November 19, 2025.
Has Park Avenue Compounding been inspected by the FDA?
The FDA last inspected Park Avenue Compounding on September 23, 2025. A Form FDA 483 was issued. FDA action on record: Regulatory Meeting Held 5/7/2026.
Has Park Avenue Compounding had any FDA drug recalls?
Park Avenue Compounding has 2 FDA drug recalls on record (2025) in the FDA enforcement database.
What does Park Avenue Compounding compound?
Park Avenue Compounding has not filed product reports with NDC-assigned drugs in the most recent FDA reporting periods.
Where is Park Avenue Compounding located?
Park Avenue Compounding is located in St. Louis, Missouri (3662 Park Ave Ste 140).
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 Park Avenue 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.