503B Docket

Pine Pharmaceuticals, LLC 503B outsourcing facility · Tonawanda, NY

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 asPine Pharmaceuticals, LLC, Tonawanda, NY
City / stateTonawanda, NY
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)716-248-1025
Initial registration date3/9/2018
Most recent registration date10/9/2026
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)11/14/2025
Form 483 issued at last inspection?Yes · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionWarning Letter Issued 8/7/2026
“Open” means FDA has not determined whether further action will be taken (per FDA's table notes).
Intends to compound sterile drugs from bulk substancesYes
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

4Form 483 records
1Warning letters
6Recall 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

NYSED Office of the Professions Verification Search (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.

Verify directly

Represent this facility? Claim this profile. Claimed profiles never change FDA records.

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. Warning letter FDA table
    Warning Letter Issued 8/7/2026
    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. Form FDA 483 Matched
    483 Issued 09/30/2024 (PDF - 18.6 MB)
    Listed on FDA page under: Pine Pharmaceuticals, Tonawanda, NY - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  5. Regulatory meeting Matched
    Regulatory Meeting Held 03/14/2024
    Listed on FDA page under: Pine Pharmaceuticals, Tonawanda, NY - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  6. Recall Matched
    Recall event 93154
    Class II · Terminated · 16 product line(s) · Recall no. D-0050-2024, D-0051-2024, D-0052-2024, D-0053-2024, D-0054-2024, D-0055-2024 …
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  7. Form FDA 483 Matched
    483 Issued 9/19/2023 (PDF - 1 MB)
    Listed on FDA page under: Pine Pharmaceuticals, Tonawanda, NY - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  8. Recall Matched
    Recall event 91972
    Class III · Terminated · 1 product line(s) · Recall no. D-0531-2023
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
    openFDA record · openFDA drug enforcement API
  9. Recall Matched
    Recall event 91378
    Class II · Terminated · 1 product line(s) · Recall no. D-0130-2023
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.
    openFDA record · openFDA drug enforcement API
  10. Recall Matched
    Recall event 90854
    Class II · Terminated · 1 product line(s) · Recall no. D-1514-2022
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  11. Form FDA 483 Matched
    483 Issued 05/14/2021 (PDF - 1 MB)
    Listed on FDA page under: Pine Pharmaceuticals, Tonawanda, NY - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  12. Recall Matched
    Recall event 79457
    Class III · Terminated · 1 product line(s) · Recall no. D-0607-2018
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
    openFDA record · openFDA drug enforcement API
  13. Recall Matched
    Recall event 72629
    Class II · Terminated · 4 product line(s) · Recall no. D-0581-2016, D-0582-2016, D-0583-2016, D-0584-2016
    Recalling firm as listed: Pine Pharmaceuticals, LLC, Tonawanda, NY. Reason: Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
    openFDA record · openFDA drug enforcement API