FDA Inspection
Steris LaboratoriesSteris Laboratories – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Steris Laboratories, with an inspection on September 13, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Steris Laboratories
- Inspection Date
- September 13, 2013
- Product Type
- Biologics
View Company Profile
ID · 1e2e91db-0d04-4b91-9b73-08c48ad02f9c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 849698
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.200(c)Calibrated per established schedules
- 21 CFR 1271.160(b)(6)Deviations--evaluation, cause, corrective action
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.160(b)(1)Ensuring appropriate core requirements followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Steris Laboratories
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | NAI | Minneapolis District Office | Postmarket Assurance: Medical Devices |
| September 22, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 12, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 23, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 15, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Steris Laboratories
- FDA Inspection 1277414 - 2025-08-01
- FDA Inspection 1028628 - 2017-09-22
- FDA Inspection 1009654 - 2017-04-12
- FDA Inspection 931470 - 2015-06-23
- FDA Inspection 862730 - 2014-01-15
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