FDA Inspection
Skoro Enterprises LLC dba XMed Oxygen Medical EquipmentSkoro Enterprises LLC dba XMed Oxygen Medical Equipment – FDA Inspection, Nov 4, 2010
Record Details
This FDA Inspection record concerns Skoro Enterprises LLC dba XMed Oxygen Medical Equipment, with an inspection on November 4, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 4, 2010
- Product Type
- Drugs
View Company Profile
ID · f6578dd8-6733-4e8b-ae45-1c34de7f0da7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 696026
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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