FDA Inspection
ProMed Systems Inc.ProMed Systems Inc. – FDA Inspection, Jun 3, 2015
Record Details
This FDA Inspection record concerns ProMed Systems Inc., with an inspection on June 3, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ProMed Systems Inc.
- Inspection Date
- June 3, 2015
- Product Type
- Biologics
View Company Profile
ID · b7ffa562-6435-442b-ade9-592acbb4c1e5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 929686
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.160(a)All core requirements covered in program
- 21 CFR 1271.195(d)Documentation not maintained
- 21 CFR 1271.200(c)Calibrated per established schedules
- 21 CFR 1271.180(a)Procedures to meet core CTGP
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