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FDA Inspection
•Precision Optics Corporation, Inc.•September 11, 2025

Precision Optics Corporation, Inc. – FDA Inspection, Sep 11, 2025

Record Details

This FDA Inspection record concerns Precision Optics Corporation, Inc., with an inspection on September 11, 2025, issued by the New England District Office, covering medical devices & rad health.

Company
Precision Optics Corporation, Inc.
Inspection Date
September 11, 2025
Product Type
Medical Devices & Rad Health
Office
New England District Office
Person
  • Jeffrey J. Thibodeau (FDA Associated Person)
View Company Profile

ID · 9c65c3ab-e572-4eb5-b766-38656cca38e2

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1282350
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

6
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
  3. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  4. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  5. 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
  6. 21 CFR 820.184DHR content

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Precision Optics Corporation, Inc.

5
DateClassificationOfficeProject area
March 31, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
June 12, 2017NAICenter for Devices and Radiological HealthBioresearch Monitoring
April 7, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
November 14, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
September 27, 2010NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Precision Optics Corporation, Inc.
  • FDA Inspection 1201925 - 2023-03-31
  • FDA Inspection 1017022 - 2017-06-12
  • FDA Inspection 965433 - 2016-04-07
  • FDA Inspection 807445 - 2012-11-14
  • FDA Inspection 685684 - 2010-09-27

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