Anybattery, Inc. – FDA Inspection, Nov 17, 2014

Record Details

This FDA Inspection record concerns Anybattery, Inc., with an inspection on November 17, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Anybattery, Inc.
Inspection Date: November 17, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · b97ced85-4ce3-48bc-8a5c-9ae3c86a8488

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 902024
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(a)Design control - no procedures
21 CFR 820.184Lack of or inadequate DHR procedures
21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
21 CFR 820.20(c)Management review - Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ

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Other FDA inspections of Anybattery, Inc.

Date	Classification	Office	Project area
September 26, 2024	NAI	Center for Devices and Radiological Health	Compliance: Devices
December 16, 2015	VAI	Center for Devices and Radiological Health	Compliance: Devices