Nephron SC, LLC - 634647 - 05/08/2026

Quick Take

The FDA has issued a formal warning letter to Nephron SC, LLC, citing the production of adulterated drug products within its compounding pharmacy operations. This regulatory action (Warning Letter 634647) signals significant concerns regarding the facility's adherence to manufacturing safety and quality standards.

Why It Matters

Compounding pharmacies are critical suppliers for eye care practices, providing essential medications such as fortified antibiotics, specialized dilating drops, and surgical adjuncts. When a major compounder is cited for producing adulterated products, it raises immediate concerns regarding sterility and potency, potentially putting patients at risk for infection or sub-therapeutic outcomes. Furthermore, such regulatory actions often precede product recalls or supply shortages, requiring practices to quickly pivot their sourcing strategies to maintain clinical operations.

Key Details

• The FDA issued Warning Letter 634647 to Nephron SC, LLC on May 8, 2026.
• The citation specifically identifies the production and distribution of adulterated drug products.
• The facility in question operates as a compounding pharmacy, which typically serves healthcare providers and surgical centers.
• The warning follows regulatory inspections that identified failures to meet required manufacturing standards.

Practice Implications

Clinicians should immediately review their current inventory for any medications sourced from Nephron SC, LLC to assess potential risks.Practice managers should consider identifying and vetting alternative compounding suppliers to ensure a stable supply of essential office-use medications.Providers should remain vigilant for any specific product recall notices or adverse event reports associated with this facility's output.

Who's Affected