FDA Inspection
Assure Infusions, IncAssure Infusions, Inc – FDA Inspection, Sep 17, 2026
Record Details
This FDA Inspection record concerns Assure Infusions, Inc, with an inspection on September 17, 2026, issued by the Florida District Office, covering human drugs.
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ID · f0cf5f0d-4162-4f97-ba6f-ebc808e0cffb
Inspection Facts
- Inspection number
- 1332640
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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