FDA Inspection
TRUECARE BIOMEDIXTRUECARE BIOMEDIX – FDA Inspection, Nov 3, 2017
Record Details
This FDA Inspection record concerns TRUECARE BIOMEDIX, with an inspection on November 3, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · d905f684-c529-4fa3-96a6-216cf8c347ec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030939
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
13- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.188(b)(8)Labeling Control Records and Label Copies
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of TRUECARE BIOMEDIX
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | Not classified | Office of Inspections and Investigations | |
| March 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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