FDA Inspection
BREATHE EASY THERAPEUTICS IncBREATHE EASY THERAPEUTICS Inc – FDA Inspection, Jan 25, 2010
Record Details
This FDA Inspection record concerns BREATHE EASY THERAPEUTICS Inc, with an inspection on January 25, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- January 25, 2010
- Product Type
- Drugs
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ID · d7a935e9-1c9e-416b-a548-d4c016d3f47b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 642941
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(a)Lack of quality control unit
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