503Pharma Compliance Intelligence

Hey there,

This week's case hit close to home for anyone doing both sterile and non-sterile compounding. An Indiana 503A got a 10-observation FDA 483 in November 2024. The findings paint a picture of environmental control breakdown that built up over time.

📋 THIS WEEK'S CASE

Location: Indianapolis, Indiana
Facility Type: 503A — Sterile and Non-Sterile Drug Producer
Inspection Dates: November 13–22, 2024
FDA 483 Issued: November 22, 2024

This pharmacy compounds sterile IV preparations and non-sterile hazardous drugs. They'd already received a Warning Letter in November 2021 for similar issues.

WHAT HAPPENED

The FDA investigator arrived and observed compounding in real-time:

• Dead insects in the Biosafety Cabinets. During Estradiol capsule compounding, the investigator found dead mosquitoes and other unidentified insects on the BSC exhaust layer. The pharmacy had been compounding in this suite since April 2023—19 months before anyone noticed.

• A live spider in the compounding room. Found in a corner beneath a cart holding two mixers.

• Fungal and mold growth documented months earlier—and ignored. The pharmacy's own June 2024 environmental sampling report showed fungal growth in surface samples and mold in air samples. Compounding continued for five more months until the FDA showed up.

• ISO 5 hood in an unclassified room. The LAFH used for sterile IV mixing sat in an unclassified room since April 2021—over three years. The June 2024 certification didn't even include a room classification.

• Media fills that don't reflect reality. Media fills simulated a single IV bag. Technicians actually prepared dozens per session.

• Cleaning without sporicidal agents. Despite documented fungal growth, a technician cleaned the ISO 5 LAFH without sporicidal agents. Yellow stains remained on the HEPA filter after cleaning. A dirty cart sat next to the hood during active compounding.

• Non-sterile supplies in critical areas. Wipes used to disinfect vials had no sterility designation. Syringes and needles entered the ISO 5 without disinfection. Sterile wipes were left open in unclassified areas.

WHY THIS MATTERS FOR ALL OF US

1. Your environmental monitoring data means nothing if you don't act on it. This pharmacy had fungal growth documented in June 2024. Five months later, the FDA found insects in the hoods.

2. Media fills must reflect your actual worst day. A single-unit simulation tells you nothing about fatigue, technique drift, or airflow disruption during real production.

3. Cleaning is a system, not a task. Sporadic sporicidal use after documenting fungal growth signals a program that exists on paper but not in practice.

4. The FDA looks at the environment first. Insects, visible contamination, exposed skin, rapid movements—these are immediate red flags that trigger deeper scrutiny.

🛡️ BUILDING SYSTEMS THAT CATCH THIS

Environmental monitoring only works if you act on what it finds. This pharmacy had fungal growth documented in June. Five months later, the FDA found insects in the hoods.

Here's how CompoundLearn helps you stay ahead:

Training Modules Build competency in environmental control with DP-3: Facility & Environmental Controls and DP-4: Quality Assurance Program—so your team understands ISO classifications, cleaning validation, and how to run a CAPA process when EM results go sideways.

SOP Library Access ready-to-use procedures for environmental monitoring response, cleaning and disinfection schedules, and media fill protocols. Don't reinvent the wheel—customize proven templates.

Competencies Assign and track role-specific qualifications. Ensure the person reviewing EM data knows what fungal growth requires. Document who's trained on what.

Templates Generate environmental monitoring logs, cleaning verification records, and deviation reports. Audit-ready documentation that takes seconds to create.

Assessments Verify that your team can identify contamination risks and respond appropriately. Document the results automatically.

✅ THIS WEEK'S ACTION ITEM

Review your last 6 months of environmental monitoring data. Did you have any samples with growth? What investigation was documented? What corrective actions were implemented? Are they still in place?

If you can't answer all four with documentation, you have a gap. Close it before someone else finds it.

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✉️ That’s your 503Pharma Intel Brief. Our mission is to keep compounding professionals informed, prepared, and ahead of the curve.