FDA Inspection
Eugia US Manufacturing LLCEugia US Manufacturing LLC – FDA Inspection, Dec 22, 2023
Record Details
This FDA Inspection record concerns Eugia US Manufacturing LLC, with an inspection on December 22, 2023, issued by the New Jersey District Office.
- Company
- Eugia US Manufacturing LLC
- Inspection Date
- December 22, 2023
View Company Profile
ID · 190e7ff2-47f5-4ed9-a102-176c9d19e6ec
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1226120
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.170(b)Investigation of reserve sample deterioration
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.68(b)input/output verification
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