FDA Inspection
Helm Surgical Systems LLCHelm Surgical Systems LLC – FDA Inspection, Oct 6, 2011
Record Details
This FDA Inspection record concerns Helm Surgical Systems LLC, with an inspection on October 6, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Helm Surgical Systems LLC
- Inspection Date
- October 6, 2011
- Product Type
- Biologics
View Company Profile
ID · 469961cc-0ea1-41b8-80e7-b4090b8ca309
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 748995
- 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 1271.160(d)Documentation/approval prior to implementation
- 21 CFR 1271.170(c)Trained or re-trained as necessary
- 21 CFR 1271.180(a)Procedures to meet core CTGP
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Other FDA inspections of Helm Surgical Systems LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2012 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Helm Surgical Systems LLC
- FDA Inspection 805131 - 2012-10-26
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