503B Docket

SCA Pharmaceuticals 503B outsourcing facility · Windsor, CT

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 asSCA Pharmaceuticals, Windsor, CT
City / stateWindsor, CT
FDA's table lists city and state only, not a street address.
Contact phone (as listed by FDA)877-550-5059
Initial registration date8/3/2017
Most recent registration date12/8/2025
Outsourcing facilities must re-register annually (Oct 1 – Dec 31) to remain on FDA's list.
Last inspection (FDA table)3/13/2026
Form 483 issued at last inspection?Yes · View Form 483 (FDA PDF)
Recall conducted? (FDA table)No
Action based on last inspectionOpen7
“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
0Warning letters
14Recall 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

Connecticut eLicense Lookup (Commission 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. Inspection FDA table
    Last inspection per FDA table; Form 483 issued: Yes
    FDA document · FDA registered outsourcing facilities table
  2. Form FDA 483 FDA table
    Form FDA 483 (linked from FDA's registration table)
    FDA document · FDA registered outsourcing facilities table
  3. FMD-145 letter Matched
    FMD-145 Letter Issued 04/17/2025
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  4. Form FDA 483 Matched
    483 Issued 12/20/2024 (PDF - 2.45 MB)
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  5. Firm response to Form 483 Matched
    483 Response Dated 11/10/2023 (PDF - 360 KB)
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  6. Recall Matched
    Recall event 93456
    Class II · Terminated · 32 product line(s) · Recall no. D-0394-2024, D-0395-2024, D-0396-2024, D-0397-2024, D-0398-2024, D-0399-2024 …
    Recalling firm as listed: SCA Pharmaceuticals, LLC, Windsor, CT. Reason: Lack of Assurance of Sterility
    openFDA record · openFDA drug enforcement API
  7. Form FDA 483 Matched
    483 Issued 10/20/2023 (PDF - 642 KB)
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  8. Recall Matched
    Recall event 92737
    Class II · Terminated · 1 product line(s) · Recall no. D-0945-2023
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: cGMP deviations: due to shipment of rejected units.
    openFDA record · openFDA drug enforcement API
  9. Recall Matched
    Recall event 92073
    Class III · Terminated · 1 product line(s) · Recall no. D-0555-2023
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Subpotent Drug: Out of specification results for low potency was obtained.
    openFDA record · openFDA drug enforcement API
  10. Recall Matched
    Recall event 91774
    Class III · Terminated · 1 product line(s) · Recall no. D-0363-2023
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Subpotent Drug
    openFDA record · openFDA drug enforcement API
  11. Recall Matched
    Recall event 90080
    Class II · Terminated · 3 product line(s) · Recall no. D-0829-2022, D-0830-2022, D-0831-2022
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: CGMP Deviations
    openFDA record · openFDA drug enforcement API
  12. FMD-145 letter Matched
    FMD-145 Letter Issued 10/22/2021
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    No document link published · FDA Compounding: Inspections, Recalls, and other Actions
  13. Recall Matched
    Recall event 86990
    Class II, Class III · Terminated · 32 product line(s) · Recall no. D-0186-2021, D-0187-2021, D-0188-2021, D-0189-2021, D-0190-2021, D-0191-2021 …
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
    openFDA record · openFDA drug enforcement API
  14. Recall Matched
    Recall event 86802
    Class III · Terminated · 1 product line(s) · Recall no. D-0147-2021
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Subpotency: Out-of-specification stability test result for low potency was obtained.
    openFDA record · openFDA drug enforcement API
  15. Recall Matched
    Recall event 86193
    Class I · Terminated · 4 product line(s) · Recall no. D-1550-2020, D-1551-2020, D-1552-2020, D-1553-2020
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
    openFDA record · openFDA drug enforcement API
  16. Recall Matched
    Recall event 86194
    Class II · Terminated · 1 product line(s) · Recall no. D-1495-2020
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
    openFDA record · openFDA drug enforcement API
  17. Recall Matched
    Recall event 85865
    Class II · Terminated · 1 product line(s) · Recall no. D-1311-2020
    Recalling firm as listed: SCA Pharmaceuticals, Windsor, CT. Reason: Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
    openFDA record · openFDA drug enforcement API
  18. Recall Matched
    Recall event 84326
    Class II · Terminated · 1 product line(s) · Recall no. D-0620-2020
    Recalling firm as listed: SCA Pharmaceuticals, LLC, Windsor, CT. Reason: Presence of Foreign Substance: Foreign material found inside the vial (manufacturer).
    openFDA record · openFDA drug enforcement API
  19. Form FDA 483 Matched
    483 Issued 11/19/2019 (PDF - 1 MB)
    Listed on FDA page under: SCA Pharmaceuticals, LLC., Windsor, CT - 503B Facility
    FDA document · FDA Compounding: Inspections, Recalls, and other Actions
  20. Recall Matched
    Recall event 83580
    Class II · Terminated · 1 product line(s) · Recall no. D-1843-2019
    Recalling firm as listed: SCA Pharmaceuticals, LLC, Windsor, CT. Reason: Lack of Assurance of Sterility.
    openFDA record · openFDA drug enforcement API
  21. Recall Matched
    Recall event 80303
    Class II · Terminated · 12 product line(s) · Recall no. D-0894-2018, D-0895-2018, D-0896-2018, D-0897-2018, D-0898-2018, D-0899-2018 …
    Recalling firm as listed: SCA Pharmaceuticals, LLC, Windsor, CT. Reason: Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
    openFDA record · openFDA drug enforcement API
  22. Recall Matched
    Recall event 79265
    Class III · Terminated · 1 product line(s) · Recall no. D-0603-2018
    Recalling firm as listed: SCA Pharmaceuticals, LLC., Windsor, CT. Reason: Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
    openFDA record · openFDA drug enforcement API