For healthcare providers who rely on 503B outsourcing facilities for compounded medications, staying informed about FDA inspection outcomes is a critical part of vendor management. This page tracks the latest FDA inspection results, Form 483 observations, and warning letters issued to 503B outsourcing facilities during the 2025-2026 inspection cycle.
Understanding FDA Inspection Results
Before reviewing specific facility results, it helps to understand the types of enforcement actions the FDA can take following an inspection of a 503B outsourcing facility.
Form 483 Observations
An FDA Form 483 is a document issued at the conclusion of an inspection when the FDA investigator has observed conditions that may violate the Federal Food, Drug, and Cosmetic Act. Receiving a Form 483 does not necessarily mean a facility is non-compliant; it means the FDA identified areas that require attention.
Common Form 483 observations for 503B facilities include deficiencies in aseptic processing, environmental monitoring, documentation, quality control testing, and equipment maintenance. For a detailed guide to understanding and responding to Form 483s, see our comprehensive Form 483 guide.
Warning Letters
A warning letter is a more serious enforcement action. The FDA issues warning letters when it finds significant violations that require immediate corrective action. Warning letters are public documents and can indicate systemic quality issues at a facility.
FMD-145 Notices
An FMD-145 notice is a formal FDA notification related to drug quality or safety concerns. These notices may be issued when the FDA identifies specific product quality issues, contamination events, or other safety-related findings.
Notable 2025-2026 FDA Inspection Results
BPI Labs LLC — Largo, Florida
BPI Labs is one of the most searched 503B outsourcing facilities in the United States, and its 2025 FDA inspection results have generated significant interest from healthcare providers and industry observers.
BPI Labs received an FDA Form 483 following its 2025 inspection. The observations focused on areas common to sterile compounding operations, including quality system oversight and manufacturing process controls.
Key details:
- Facility: BPI Labs LLC
- Location: Largo, Florida
- Inspection Type: Routine cGMP inspection
- Action: Form 483 issued
- Status: Facility response submitted to FDA
Healthcare providers should review BPI Labs' response to the Form 483 and any subsequent FDA actions when evaluating the facility as a compounding partner. View the full BPI Labs facility profile for the latest compliance information.
Eagle Pharma Outsourcing — Birmingham, Alabama
Eagle Pharma Outsourcing also received FDA attention during the 2025 inspection cycle. The facility, located in Birmingham, Alabama, was the subject of a Form 483 following a routine FDA inspection.
Key details:
- Facility: Eagle Pharma
- Location: Birmingham, Alabama
- Inspection Type: Routine cGMP inspection
- Action: Form 483 issued
- Status: Under review
View the full Eagle Pharma facility profile for current compliance data.
Fagron Sterile Services — Canton, Massachusetts
Fresenius Kabi Compounding LLC (dba Fagron Sterile Services) operates one of the largest 503B outsourcing facilities in the country from its Canton, Massachusetts location. Fagron's inspection history is closely watched given the facility's significant market presence.
Key details:
- Facility: Fresenius Kabi Compounding LLC dba Fagron Sterile Services
- Location: Canton, Massachusetts
- Inspection History: Subject to regular FDA inspections given facility scale
View the full Fagron Sterile Services facility profile for the latest inspection data.
Other Notable 2025-2026 Inspections
The FDA continues its risk-based inspection program across all registered 503B outsourcing facilities. Other facilities that have been subject to recent FDA inspection activity include:
- Empower Pharma (Houston, TX) — One of the largest 503B facilities, subject to ongoing regulatory scrutiny. View profile
- SCA Pharmaceuticals (Windsor, CT) — Major sterile compounding operation. View profile
- Nephron Sterile Compounding Center (West Columbia, SC) — Large-scale sterile manufacturer. View profile
- Integradose Compounding Services (Minneapolis, MN) — Subject to FDA oversight. View profile
- Quva Pharma (Bloomsbury, NJ) — Major sterile compounding facility. View profile
How to Research Any Facility's Inspection History
You do not need to wait for this page to be updated to research a specific facility. Here is how to find inspection records yourself:
Using Our Directory
- Visit our 503B pharmacy directory and search for the facility by name
- Click on the facility to view its full profile
- The profile page shows the facility's inspection history, including dates, outcomes, and any Form 483 observations or warning letters
Using the FDA's Databases
- FDA Inspections Database: Search the FDA Inspection Observations database for Form 483 records
- Warning Letters Database: Search the FDA Warning Letters database for enforcement actions
- Registered Outsourcing Facilities: Confirm current registration status on the FDA's registered facilities list
What to Look For
When evaluating a facility's inspection history, consider:
- Frequency of inspections: More frequent inspections may indicate the FDA has identified the facility as higher risk
- Nature of observations: Are the findings related to critical quality controls (sterility, potency) or administrative documentation?
- Facility response: Did the facility promptly address the observations with adequate corrective actions?
- Repeat observations: Are the same issues appearing across multiple inspections? This may indicate systemic problems
- Escalation pattern: Has the FDA escalated from Form 483 to warning letter to consent decree? This indicates worsening compliance
What Inspection Results Mean for Healthcare Providers
FDA inspection results should be one factor in your overall vendor evaluation process. Here is how to put them in context:
- A Form 483 alone is not disqualifying. Most 503B facilities receive Form 483 observations at some point. What matters is how the facility responds and whether it implements effective corrective and preventive actions (CAPA).
- Warning letters warrant serious attention. A warning letter indicates the FDA found significant violations. Facilities with outstanding warning letters should be evaluated with additional scrutiny, and you should request documentation of corrective actions before continuing to source from them.
- No inspection record is not necessarily positive. If a facility has no recent inspection history, it may simply mean the FDA has not yet inspected it. This is not the same as a clean record.
- Look at the trend, not just the snapshot. A facility that had issues in the past but has demonstrated sustained improvement may be a better partner than one with a clean record but limited inspection history.
Stay Informed
This page is updated as new FDA inspection data becomes available. For the most current information on any specific facility, use our interactive 503B pharmacy directory or consult the FDA's databases directly.
You can also read our related guides: