503B Docket

Park Avenue Compounding 503B outsourcing facility · St. Louis, MO

This is a record of what FDA published, not a rating. Last FDA inspection and Form 483 status below are as published in FDA's registered outsourcing facilities table (as of Sep 30, 2026).

FDA registration record

Listed by FDA asPark Avenue Compounding, St. Louis, MO
City / stateSt. Louis, MO
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)603-953-6675
Initial registration date12/23/2023
Most recent registration date11/19/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)9/23/2025
Form 483 issued at last inspection?Yes · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionRegulatory Meeting Held 5/7/2026
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesNo
Self-reported by the facility at registration; FDA notes this information has not been verified by FDA.

Source: FDA Registered Outsourcing Facilities

Published FDA records

1Form 483 records
0Warning letters
2Recall events (openFDA)
0Uncertain-match items

Counts include only items from FDA's table or exact name + city + state matches. They are counts of published records, not a score. Uncertain matches are shown below but not counted.

State board of pharmacy license lookup

Missouri Division of Professional Registration Licensee Search (Board of Pharmacy) (license lookup)

Search the state board's lookup for this facility's license status and any disciplinary actions. We link to the state-level tool only and do not list license numbers. FDA's table does not include state board actions. Facilities that ship across state lines may also hold non-resident licenses in your state, so check your own state's board too.

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Timeline of FDA actions

Newest first. Sources: FDA's registration table, FDA's compounding actions page (2019 onward on the live page), and openFDA drug enforcement records. Items marked Uncertain match may relate to a different site or entity and are not counted. How matching works.

  1. Regulatory meeting FDA table
    Regulatory Meeting Held 5/7/2026
    No document link published · FDA registered outsourcing facilities table
  2. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    FDA document · FDA registered outsourcing facilities table
  3. Form FDA 483 FDA table
    Form FDA 483 (linked from FDA's registration table)
    FDA document · FDA registered outsourcing facilities table
  4. Recall Matched
    Recall event 97938
    Class II · Ongoing · 1 product line(s) · Recall no. D-0178-2026
    Recalling firm as listed: Park Avenue Compounding, Saint Louis, MO. Reason: CGMP Deviations: Revised interpretation of Acceptable Quality Level (AQL) results.
    openFDA record · openFDA drug enforcement API
  5. Recall Matched
    Recall event 97960
    Class II · Ongoing · 1 product line(s) · Recall no. D-0200-2026
    Recalling firm as listed: Park Avenue Compounding, Saint Louis, MO. Reason: CGMP Deviations
    openFDA record · openFDA drug enforcement API