FDA Inspection
Aerosprays IncAerosprays Inc – FDA Inspection, Nov 6, 2013
Record Details
This FDA Inspection record concerns Aerosprays Inc, with an inspection on November 6, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Aerosprays Inc
- Inspection Date
- November 6, 2013
- Product Type
- Drugs
View Company Profile
ID · 3cc56eb4-1edb-4c42-ac9b-c39fa5b8a76d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854499
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.184(d)Labeling: documentation of exam and review
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