SCA Pharmaceuticals
FDA 503B outsourcing facility
Windsor, Connecticut
Key Takeaways
- FDA-registered 503B outsourcing facility since 2017
- Sterile compounding from bulk substances: Yes
- Last FDA inspection: March 13, 2026
- 166 FDA drug recalls on record (2015 to 2023)
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
- August 3, 2017
- Most recent registration
- December 8, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- March 13, 2026
The FDA last inspected SCA Pharmaceuticals on March 13, 2026. Investigators issued a Form FDA 483 listing inspectional observations at that visit. The FDA has not yet determined whether further action will be taken.
FDA recall history
SCA Pharmaceuticals has 166 FDA drug recalls on record between 2015 and 2023, based on the FDA enforcement database. Breakdown: 12 Class I, 149 Class II, 5 Class III.
Recall reasons on record include lack of assurance of sterility; cgmp deviations: due to shipment of rejected units; subpotent drug: out of specification results for low potency was obtained; subpotent drug; cgmp deviations.
| Date | Class | Product | Reason |
|---|---|---|---|
| November 2023 | Class II | PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceutical | Lack of Assurance of Sterility |
| November 2023 | Class II | labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC | Lack of Assurance of Sterility |
| November 2023 | Class II | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, | Lack of Assurance of Sterility |
| November 2023 | Class II | PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 160 mcg/mL), 250 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainb | Lack of Assurance of Sterility |
| November 2023 | Class II | fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONL | Lack of Assurance of Sterility |
Showing the 5 most recent of 166 recall events.
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.
What this facility compounds
SCA Pharmaceuticals reports compounding 22 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Oxytocin.
- Diltiazem Hydrochloride
- Ephedrine Sulfate
- Epinephrine
- Fentanyl Citrate
- Fentanyl Citrate; Bupivacaine Hydrochloride
- Fentanyl Citrate; Ropivacaine Hydrochloride
- Hydromorphone Hydrochloride
- Ketamine Hydrochloride
- Labetalol Hydrochloride
- Lidocaine Hydrochloride
- Methadone Hydrochloride
- Morphine Sulfate Anhydrous
- Norepinephrine Bitartrate
- Oxytocin
- Phenylephrine Hydrochloride
- Potassium Chloride
- Potassium Phosphate, Dibasic; Potassium Phosphate, Monobasic
- Rocuronium Bromide
- Succinylcholine Chloride
- Sugammadex Sodium
- Trisodium Citrate Dihydrate
- Vancomycin Hydrochloride
Location
755 Rainbow Rd Ste B, N/A, Windsor, CT 06095-1024
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Contact
FDA-registered contact: Joanna DiStefano, 877-550-5059. 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 SCA Pharmaceuticals with the Connecticut Commission of Pharmacy.
503B facilities in Connecticut
SCA Pharmaceuticals also operates a registered 503B facility at Little Rock, AR.
Connecticut has 2 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in Connecticut.
Frequently asked questions
Is SCA Pharmaceuticals registered with the FDA?
Yes. SCA Pharmaceuticals is a registered 503B outsourcing facility, first registered with the FDA on August 3, 2017 and most recently registered on December 8, 2025.
Has SCA Pharmaceuticals been inspected by the FDA?
The FDA last inspected SCA Pharmaceuticals on March 13, 2026. A Form FDA 483 was issued.
Has SCA Pharmaceuticals had any FDA drug recalls?
SCA Pharmaceuticals has 166 FDA drug recalls on record (2015 to 2023) in the FDA enforcement database.
What does SCA Pharmaceuticals compound?
SCA Pharmaceuticals reports compounding 22 active ingredients to the FDA, including Oxytocin.
Where is SCA Pharmaceuticals located?
SCA Pharmaceuticals is located in Windsor, Connecticut (755 Rainbow Rd Ste B).
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 SCA Pharmaceuticals. 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.