FDA 483 - LGM Pharma Solutions LLC - August 06, 2025

LGM Pharma Solutions, LLC. in Rosenberg, TX, was inspected and cited for significant deficiencies across its drug manufacturing operations. The inspection revealed issues with facility contamination control, equipment maintenance, building repair, and an inadequate number of qualified personnel, indicating a broad lack of GMP compliance. These conditions pose risks to product quality and safety.