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FDA Inspection
•Next Medical Products Company, LLC•July 31, 2017

Next Medical Products Company, LLC – FDA Inspection, Jul 31, 2017

Record Details

This FDA Inspection record concerns Next Medical Products Company, LLC, with an inspection on July 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Next Medical Products Company, LLC
Inspection Date
July 31, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
People
  • Frank J. Marciniak (Issuing Officer)
  • Gobiga Vanniyasingam (Company Rep)
View Company Profile

ID · 786683f6-7fba-4164-96e9-44b08ff1bb31

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1020345
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

6
  1. 21 CFR 820.184DHR - not or inadequately maintained
  2. 21 CFR 820.40Procedures not adequately established or maintained
  3. 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
  4. 21 CFR 820.100(a)Lack of or inadequate procedures
  5. 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
  6. 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Next Medical Products Company, LLC

6
DateClassificationOfficeProject area
December 10, 2025Not classifiedNew Jersey District OfficeCompliance: Medical Devices
June 21, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
April 7, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
October 4, 2021VAICenter for Devices and Radiological HealthCompliance: Devices
March 12, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
View all 6 other inspections on the company page
Other documents for Next Medical Products Company, LLC
  • FDA Inspection 1294634 - 2025-12-10
  • FDA Inspection 1241732 - 2024-06-21
  • FDA Inspection 1201963 - 2023-04-07
  • FDA Inspection 1154325 - 2021-10-04
  • FDA Inspection 821982 - 2013-03-12

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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