FDA Inspection
PCCI, Inc.PCCI, Inc. – FDA Inspection, May 22, 2025
Record Details
This FDA Inspection record concerns PCCI, Inc., with an inspection on May 22, 2025, issued by the Baltimore District Office, covering medical devices & rad health.
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ID · 88460332-e664-4744-8701-6a55c8241ebe
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1270477
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of PCCI, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for PCCI, Inc.
- FDA Inspection 1159988 - 2021-12-02
- FDA Inspection 1062806 - 2018-08-16
- FDA Inspection 898200 - 2014-10-08
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