This draft focuses on the public health risk of selling compromised medical devices and pharmaceuticals. You can submit this through the FDA’s MedWatch portal or their Safety Reporting Portal.

Draft Regulatory Tip for the FDA

Subject: Systemic Storage Failures and Lack of Temperature Monitoring for Medical Devices and OTC Pharmaceuticals

Entity Name: Dollar General (Store #[Insert Store Number if known] / [City, State])
Incident Location: Backroom Inventory Storage Area

Description of Issue:
I am reporting a systemic failure to maintain and monitor safe storage temperatures for regulated medical devices (specifically condoms) and Over-the-Counter (OTC) pharmaceuticals at Dollar General.

Key Facts:

• Temperature Excursions: Regulated products are routinely stored in the facility's backroom, where ambient air temperatures frequently exceed safe storage limits (above 77°F for CRT products and above 100°F for medical devices).
• Lack of Monitoring: Management has failed to implement any ambient air temperature logging or monitoring systems in the backroom. There are no records to document the duration or severity of these temperature excursions.
• Product Impact: Prolonged exposure to high heat and humidity has resulted in visible product degradation, including [mention any details like melted gummies, leaking lubricants, or medicine capsules sticking together].
• Under-staffing & Hazards: Due to severe under-staffing, inventory (including medicines and condoms) remains in these unmonitored backroom conditions for extended periods, often weeks, before being moved to the sales floor.
• Software Failure: Internal inventory adjustment systems are currently failing to accurately track on-hand quantities, further delaying the identification and removal of expired or heat-damaged products.

Safety Concern:
The sale of these compromised products poses a significant risk to consumer health, as heat-damaged condoms are prone to breakage and degraded pharmaceuticals may lose potency or produce toxic byproducts.

Next Steps for You

1. Gather Evidence: If you can safely do so, take a photo of a thermometer in the backroom showing a high temperature or a photo of the blocked/cluttered inventory.
2. Submit to the FDA: Go to the FDA MedWatch Online Form and copy/paste the draft above into the "Describe Event or Problem" section.
3. Contact your State Board: Search for your [State] Board of Pharmacy and find their "File a Complaint" link to report the medicine storage issues.

Would you like me to adjust this draft to focus more on the inventory software failure for a report to the SEC or IRS instead?