McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions
FDA 503B outsourcing facility
Santa Ana, California
Key Takeaways
- FDA-registered 503B outsourcing facility since 2023
- Sterile compounding from bulk substances: Yes
- Not yet inspected by the FDA
- 4 FDA drug recalls on record (2019 to 2022)
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
- January 11, 2023
- Most recent registration
- December 2, 2025
- Compounds sterile drugs from bulk substances
- Yes
- Last FDA inspection
- Not yet inspected
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions has registered with the FDA as a 503B outsourcing facility but has not yet been inspected. The FDA inspects registered facilities on a risk-based schedule once drug production and distribution are confirmed.
FDA recall history
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions has 4 FDA drug recalls on record between 2019 and 2022, based on the FDA enforcement database. Breakdown: 4 Class II.
Recall reasons on record include presence of particulate matter: presence of foreign substances were reported in vials at; presence of particulate matter: particulates observed in vials release for dispensing; presence of particulate matter: filmy/cloudy particulate observed in vial.
| Date | Class | Product | Reason |
|---|---|---|---|
| December 2022 | Class II | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Steril | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. |
| December 2022 | Class II | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. |
| February 2019 | Class II | Dimercaptopropanesulfonate Sodium (DMPS), Aqueous injection solution, 50mg/mL 5 mL SDV, Rx only, McGuff Compounding Pharmacy Services, Inc. | Presence of Particulate Matter: Particulates observed in vials release for dispensing. |
| January 2019 | Class II | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic Acid), 1,200 mg/30 mL (40 mg/mL) Sterile 30 mL Multiple Dose Vial, Rx Only, McGuff | Presence of Particulate Matter: filmy/cloudy particulate observed in vial. |
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
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions reports compounding 4 distinct active ingredients to the FDA Outsourcing Facility Product Report (most recent reporting periods).
Tracked on PeptideGrids: Glutathione.
- Alpha Lipoic Acid
- Glutathione
- Methylcobalamin
- Procaine Hydrochloride
Location
2921 W Macarthur Blvd Ste 142, N/A, Santa Ana, CA 92704-7944
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Contact
FDA-registered contact: Jacqueline McKay Ext 314, 714-918-7277. 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 McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions with the California State Board of Pharmacy.
503B facilities in California
California has 7 FDA-registered 503B outsourcing facilities in the PeptideGrids directory. See all 503B facilities in California.
Frequently asked questions
Is McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions registered with the FDA?
Yes. McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions is a registered 503B outsourcing facility, first registered with the FDA on January 11, 2023 and most recently registered on December 2, 2025.
Has McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions been inspected by the FDA?
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions has registered with the FDA but has not yet been inspected as a 503B outsourcing facility.
Has McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions had any FDA drug recalls?
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions has 4 FDA drug recalls on record (2019 to 2022) in the FDA enforcement database.
What does McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions compound?
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions reports compounding 4 active ingredients to the FDA, including Glutathione.
Where is McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions located?
McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions is located in Santa Ana, California (2921 W Macarthur Blvd Ste 142).
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 McGuff Pharmaceuticals, Inc. dba McGuff Outsourcing Solutions. 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.