FDA Inspection
Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim SirketiNeva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi – FDA Inspection, Sep 20, 2024
Record Details
This FDA Inspection record concerns Neva Global Grup Sanayi Ic Ve Dis Ticaret Anonim Sirketi, with an inspection on September 20, 2024, issued by the Office of Inspections and Investigations, covering human drugs.
- Inspection Date
- September 20, 2024
- Product Type
- Human Drugs
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ID · 74370881-03bd-4592-ade5-52957e855437
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1250169
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
12- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)(3)Acceptance of drug products
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.84(d)(2)Component identification test
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.180(e)(1)Representative Number of Batches for Annual Review
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