FDA Inspection
Sciarra Laboratories, Inc.Sciarra Laboratories, Inc. – FDA Inspection, Aug 7, 2023
Record Details
This FDA Inspection record concerns Sciarra Laboratories, Inc., with an inspection on August 7, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 8cda42d2-1518-41f1-9d52-7cb809baa777
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1211562
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.166(a)Written program not followed
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Sciarra Laboratories, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 1046128 - 2018-03-29
- FDA Inspection 1041616 - 2018-02-14
- FDA Inspection 925624 - 2015-05-05
- FDA Inspection 867806 - 2014-02-07
- FDA Inspection 802381 - 2012-10-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.