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  • FDA Warning Letters


    1. Warning Letter: Failure to establish validation procedures (ucm268244)

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      Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

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    2. Warning Letter: Failure to establish procedures (ucm268059)

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      Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures. You also have no documentation of design validation or design change controls for the Antalgic-Trak, including no documentation of risk analysis or structural [redacted] testing of the embedded software.

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    3. Warning Letter: Failure to follow procedures (ucm268034)

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      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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    4. Warning Letter: Failure to validate computer software (ucm265239)

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      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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    5. Warning Letter: Failure to document software validation (ucm258853)

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      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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    6. Warning Letter: Failure to provide validation documentation (ucm257575)

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      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.

      View the original warning letter.


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    7. Warning Letter: Failure to validate Excel Spreadsheet (ucm256498)

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      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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    8. Warning Letter: Failure to exercise appropriate controls (ucm253467)

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      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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    9. Warning Letter: Failure to conduct complete validation (ucm255936)

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      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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    10. Warning Letter: Lack of documentation (ucm253235)

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      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)).

      View the original warning letter.


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