IGMPI India



USFDA issues warning letter to Natus Medical Incorporated

USFDA has issued warning letter to Seattle located Natus Medical Incorporated firm on 10th April, 2015. Natus Medical Incorporated manufactures Natus neoBlue LED Phototherapy (neoBLUE) devices, which include the neoBLUE, neoBLUE 2 (with and without timer), and neoBLUE 3 systems. Inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

The violations include:

  1. Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).

  2. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).

  3. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j).

  4. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).

  5. Failure to maintain device master records (DMRs) that include, or refer to the location of, device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications, as required by 21 CFR 820.181(a).
  6. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).

FDA has given fifteen business days to the firm to correct the noted violations, as well as an explanation of how the firm plans to prevent these violations, or similar violations, from occurring again.