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FDA Inspection
•Active Creations LLC•March 7, 2019

Active Creations LLC – FDA Inspection, Mar 7, 2019

Record Details

This FDA Inspection record concerns Active Creations LLC, with an inspection on March 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company
Active Creations LLC
Inspection Date
March 7, 2019
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Esteban Beltran (Issuing Officer)
View Company Profile

ID · e26ee8aa-0f70-4c92-b1fd-99a86167c2fe

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1083114
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.184DHR - not or inadequately maintained
  3. 21 CFR 820.40(b)Document change records, maintained.
  4. 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Active Creations LLC

6
DateClassificationOfficeProject area
March 16, 2026Not classifiedNew Jersey District Office
November 2, 2021VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
June 3, 2016NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 22, 2014NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 20, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 6 other inspections on the company page
Other documents for Active Creations LLC
  • FDA Inspection 1311022 - 2026-03-16
  • FDA Inspection 1155791 - 2021-11-02
  • FDA Inspection 972692 - 2016-06-03
  • FDA Inspection 875381 - 2014-04-22
  • FDA Inspection 794732 - 2012-08-20

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