FDA Inspection
Sciarra Laboratories, Inc.Sciarra Laboratories, Inc. – FDA Inspection, Mar 29, 2018
Record Details
This FDA Inspection record concerns Sciarra Laboratories, Inc., with an inspection on March 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 93380b86-d4be-4624-adb0-b4f3320c0464
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1046128
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sciarra Laboratories, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 5, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 7, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 4, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Sciarra Laboratories, Inc.
- FDA Inspection 1211562 - 2023-08-07
- FDA Inspection 1041616 - 2018-02-14
- FDA Inspection 925624 - 2015-05-05
- FDA Inspection 867806 - 2014-02-07
- FDA Inspection 802381 - 2012-10-04
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