Warning Letter: Failure to follow procedures (ucm268034)

Failure to establish and maintain adequate procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g).

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Warning Letter: Failure to document software validation (ucm258853)

Failure to adequately document software validation activities and results for computers or [redacted] systems used as part of production, as required by 21 CFR 820.70(i). For example, there is no documentation of validation having been performed on the software systems that operate the [redacted], which moves [redacted] pallets from [redacted] to shipping[redacted]. There are no documented quality system procedures for the control of the [redacted] finished product warehouse (UP [redacted]) and your firm’s [redacted] department does not operate within your firm’s quality system.

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Warning Letter: Failure to provide validation documentation (ucm257575)

Failure to establish and maintain procedures for validating the device design, i.e. software validation , which is required by 21 CFR 820.30(g). For example, your firm did not establish a software validation procedure or a software validation plan for software version 12.1. We acknowledge, since the release of software version 12.1 on August 27, 2008, that you have conducted a retrospective software validation for software versions 10.14-12.1; however, this was not conducted until June 8-August 20, 2010. Additionally, our inspection noted these “retrospective” testing activities lacked testing activities typically performed during a software validation, such as updated software requirements specification, a source code evaluation, and user site testing.

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Warning Letter: Failure to validate Excel Spreadsheet (ucm256498)

Failure to validate software used as part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(I). For example, your firm did not validate use of an Excel spreadsheet used to calculate the Moisture Vapor Transmission Rate (MVTR) per test procedure [redacted] Revision B.

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Warning Letter: Lack of documentation (ucm253235)

You have failed to establish and maintain a design history file (DHF) for each type of device you manufacturer that contains software. Specifically, the self-contained Triton models, the Classic Umbilical models, and the Designer Umbilical models. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements  of 21 CFR 820, (21 CFR 820.30(j)).

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Warning Letter: Failure to validate (ucm257091)

Failure to establish and maintain adequate 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). For example, your firm was unable to provide a documented design development timeline or work instruction for IMPAX CV 7.8.SU1 of the IMPAX CV 7.8 software design change that resulted in [redacted], approval for Global Release and Delivery on 7/30/2010.

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Warning Letter: Failure to validate a change (ucm252701)

Failure to establish and maintain adequate 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). For example: Your firm issued an ECN (R9180) on July 7, 2009, which changed the revision of the controller software used in the 300B and 700B model scooters from revision #8 to revision #9. This change increased the motor resistance from [redacted]. There is no documentation to indicate that this change was validated/verified .

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Warning Letter: Failure to demonstrate validation (ucm251784)

Your firm provided “Device Inspection Record” dated October 11, 2007, and Report No. SV-25 Rev 0 “Software Validation Report” dated May 30, 2008 as the only two design validations conducted for the LVT100 design project.

• Device Inspection Record” and Report No. SV-25 Rev 0 do not reference the serial numbers of the LVT100s used in the validation activities. Therefore, your firm was unable to demonstrate that these design validation activities were performed on initial production units, lots, or batches, or their equivalents. Although the person responsible stated that initial production units were used in both validations, DHRs were not maintained.
• Your firm did not develop any validation protocols for “Device Inspection Record” and Report No. SV-25 Rev 0.

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Warning Letter: Failure to allow FDA access to records (ucm256987)

Failure to permit any authorized FDA employee, at all reasonable times, to access, to copy, and to verify your complaint records, as required by 21 CFR 803.18(d)(3). For example, complaints received after September 1, 2009, and maintained in your File Maker Pro database system, could not be filtered and retrieved for review during your 2010 inspection.

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Warning Letter: Failure to validate CAPA effectiveness (ucm250065)

Failure to adequately verify or validate that the corrective and preventive action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). …. design changes were approved, but no validation or verification activity evaluating the effectiveness of the corrective action was performed or documented. Failure to validate an automated data processing system used as part of the quality system, as required by 21 CFR 820.70(i). For example: a. The CPRPlus database used from 2006 to the present to track AEDs and conduct audits of tracked AEDs was not validated.

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