FDA Inspection
SPC Home Medical EquipmentSPC Home Medical Equipment – FDA Inspection, Dec 24, 2009
Record Details
This FDA Inspection record concerns SPC Home Medical Equipment, with an inspection on December 24, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- SPC Home Medical Equipment
- Inspection Date
- December 24, 2009
- Product Type
- Drugs
View Company Profile
ID · 76b74003-5090-4714-8ad0-051153973d57
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635823
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.165(c)Sampling and testing plans not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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