FDA Inspection
Hart Medical EquipmentHart Medical Equipment – FDA Inspection, May 16, 2012
Record Details
This FDA Inspection record concerns Hart Medical Equipment, with an inspection on May 16, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Hart Medical Equipment
- Inspection Date
- May 16, 2012
- Product Type
- Drugs
View Company Profile
ID · 3f6b770b-2ef4-44b7-b281-e816a631ab08
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781735
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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