FDA Inspection 1282908 — SpecGx LLC

SpecGx LLC — FEI 1021320

The FDA completed an inspection of SpecGx LLC on September 22, 2025 in Raleigh, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 22, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Raleigh, NC (United States)