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FDA Inspection

AQ USA, INC.August 12, 2025

AQ USA, INC. – FDA Inspection, Aug 12, 2025

Record Details

This FDA Inspection record concerns AQ USA, INC., with an inspection on August 12, 2025, issued by the Seattle District Office, covering human drugs.

Company: AQ USA, INC.
Inspection Date: August 12, 2025
Product Type: Human Drugs
Office: Seattle District Office
Person: Bryan L. Mcguckin

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ID · 8b8cf907-22d1-4be4-b914-8dd65f98389e

Inspection Facts

Inspection number: 1278201
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued, view the record

FDA Citations

6

21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.188Prepared for each batch, include complete information
21 CFR 211.194(a)(6)Test results, comparison with standards not included
21 CFR 211.22(a)Lack of quality control unit
21 CFR 211.84(a)Components withheld from use pending release

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