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 validate computer software (ucm265239)

Failure to validate computer software for its intended use according to an established protocol , as required by 820.820.70(i). Your firm uses the [redacted] for in-process and final product testing for the [redacted] and the [redacted]. Your firm conducted software validation for the [redacted] and the results are included in the Software Validation Report, dated February 11, 2010.

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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 exercise appropriate controls (ucm253467)

Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)]. For example, your firm lacks control of the [redacted] computer system which monitors equipment, room differential pressure, room humidity, and stability chambers. Although the system is password protected for temperature and humidity set points, all employees have access to the room where the [redacted] computer system is located and the external hard drive is not password protected. During the inspection we observed that an employee was able to alter or delete data without a password and save the changed file.

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Warning Letter: Failure to conduct complete validation (ucm255936)

Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)]. For example, your firm went live with version 2.0.0 of the Hemocare Lifeline (HCLL) Donor Module on March 2, 2009, however, the validation of Module 15, Product Labeling, was incomplete in that it was not reviewed, accepted, or signed off by a responsible individual.

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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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