FDA Inspection
Global Treat SrlGlobal Treat Srl – FDA Inspection, Sep 13, 2019
Record Details
This FDA Inspection record concerns Global Treat Srl, with an inspection on September 13, 2019, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 5c8a0016-e1f9-406b-80bc-f085a7748f1a
Inspection Facts
- Inspection number
- 1102978
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.22(a)Lack of quality control unit
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(3)Cleaning SOPs/instructions
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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