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FDA Inspection
•Precision Forms, Inc.•May 1, 2025

Precision Forms, Inc. – FDA Inspection, May 1, 2025

Record Details

This FDA Inspection record concerns Precision Forms, Inc., with an inspection on May 1, 2025, issued by the New Jersey District Office, covering medical devices & rad health.

Company
Precision Forms, Inc.
Inspection Date
May 1, 2025
Product Type
Medical Devices & Rad Health
Office
New Jersey District Office
Person
  • Jonathan Ho (Issuing Officer)
View Company Profile

ID · 3fc69f19-737a-4165-aa81-40ceda2bf1d3

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1268441
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Medical Devices
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 820.75(a)Lack of or inadequate process validation
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Precision Forms, Inc.

4
DateClassificationOfficeProject area
August 31, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
December 4, 2019NAICenter for Devices and Radiological HealthCompliance: Devices
January 20, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
May 2, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Precision Forms, Inc.
  • FDA Inspection 1181138 - 2022-08-31
  • FDA Inspection 1118382 - 2019-12-04
  • FDA Inspection 957277 - 2016-01-20
  • FDA Inspection 831603 - 2013-05-02

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