FDA Inspection
Specialty Thearapy Equipment, Inc.Specialty Thearapy Equipment, Inc. – FDA Inspection, May 25, 2012
Record Details
This FDA Inspection record concerns Specialty Thearapy Equipment, Inc., with an inspection on May 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- May 25, 2012
- Product Type
- Devices
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ID · dbd6ad3a-da89-43f4-923d-e2c4954a959c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781184
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.200(b)Analyzing service report
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 803.17Lack of Written MDR Procedures
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