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1101435

Reliant Compounded Solutions Monroe, LLC — FEI 3012039582

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 29, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monroe, CT (United States)

Facility

Other inspections at this facility

  • 1004046 (OAI Fri Mar 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
18936FDCA 501(a)(2)(A)Non-microbial contamination, production area
18937FDCA 501(a)(2)(A)Beta-lactam drugs, inadequate sanitation
18955FDCA 501(a)(2)(A)Ceiling tiles, cleanroom
18956FDCA 501(a)(2)(A)Cleanliness, ISO-classified areas
18959FDCA 501(a)(2)(A)Location, ISO 5 classified area
18963FDCA 501(a)(2)(A)Inadequate HEPA filter, sterile product area
18970FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
18972FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
21377FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components