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    1. Warning Letter: Incomplete documentation of validation (s6741c)

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      Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR820.30(g). For example:

      a. Device software validation is incomplete. For example, the documentation of the external validation testing for the [redacted] Scanner conducted by a Canadian site in 2005 reveals incomplete sections rating the effectiveness of the scanner.

      b. Discrepancies that were noted at the completion of design validation are not addressed. For example, the final validation report for the [redacted] noted an issue regarding “streak” artifacts at one of the clinical sites; however, there was no further documented evaluation of this artifact to include significance and potential risk prior to the finalization of the design validation and commercial distribution.

      View the original warning letter.


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    2. Warning Letter: Insufficient approval signatures (s6679c)

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      No approval signatures and dates were documented for the Validation Report , [redacted]. The only approval signatures that were documented were that of the [redacted] and [redacted] from Isotron Ireland. 6. Failure to adequately establish and maintain procedures to control all documents to assure that all documents meet the requirements of this part. Those documents should include the signature of the individual(s) approving the documents and shall be documented, as required by 21 CFR 820.40(a).

      View the original warning letter.


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    3. Warning Letter: Failure to adequately establish and maintain procedures for software validation (s6730c)

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      Failure to adequately establish and maintain procedures for software validation and to perform risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example: a. Design validation of device software was not performed for some versions of the software and is inadequate for other versions. Specifically, your firm has not conducted validation of your [redacted] Software after changes to the software’s functionality have been made from your first distribution of Version [redacted] through your current Version [redacted]. Also your firm’s most current software validation of the [redacted] Software [redacted] Platform is inadequate in that the validation that was conducted for Version [redacted] consisted primarily of functional testing (black-box testing) and lacks other elements of software validation including structural testing (white-box testing).

      View the original warning letter.


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    4. Warning Letter: Failure to follow procedures (s6655c)

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      Your firm failed to establish and maintain adequate procedures to control design validation , including software validation and risk analysis, where appropriate, as required by 21 CFR 820.30(g). For example: a. Because you failed to follow your procedure, the acceptance criteria were not complete prior to the performance of validation activities. Specifically, [redacted] for ECAT scanners introduced an error in the scan start time used in the decay correction algorithm. This error was most pronounced in the TTTT/EEEE mode which was not tested during the validation of the software update.

      View the original warning letter.


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    5. Warning Letter: Inadequate employee training (s6660c)

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      Failure to ensure that all employees have the necessary training and experience to perform their jobs, as required by 21 CFR 820.25 (b). Specifically employees who manage, perform, and assess work affecting quality have not been adequately trained as members of your firm’s quality unit. Quality Assurance employees have not performed effectively in conducting complaint investigations, corrective/preventive action activities, design activities, internal audits, risk analysis and/or document reviews. You ran out of existing safety pins for the circumcision tray and a larger safety pin was substituted. You received at least two customer reports of excessive bleeding. The change to the larger safety pin was made by the Product Family Coordinator (PFC). The product authorization form was not signed and did not proceed through the change process. Other examples of inadequate employee training are the failure to implement adequate corrective and preventive actions to complaints of crystallizing alcohol in kits and a complaint of weak seals.

      View the original warning letter.


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    6. Warning Letter: Failure to validate/Insufficient Controls (s6630c)

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      Failure to have a validated and secure computerized system. Additionally, there were no written protocols to assign levels of responsibilities for the system. It was noted that the [redacted] instrument model [redacted] used for the analysis of [redacted] failed to have password control for the analysts and the supervisor. It was observed that the data stored on the computer can be deleted, removed, transferred, renamed or altered. While your firm’s management stated that they would like to implement certain improvements in order to establish a security system, no documentation or commitment has been provided. Please note that computerized systems should have sufficient controls to prevent unauthorized access or changes to data. There should be controls to prevent data omissions and assure back-up. There should be a record of any data change made, the previous entry, who made the change, and when the change was made.

      View the original warning letter.


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    7. Warning Letter: No documentation of employee training (s6597c)

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      Failure to ensure that all personnel are trained to adequately perform their assigned responsibilities; and failure to implement your training procedure, as required by 21 CFR §820.25(b). For example, there is no documentation of any training of any current employees with regard to their assigned responsibilities, although your training procedures require documentation of training. … Failure to conduct quality audits; and failure to implement audit procedures to assure that the quality system is in compliance with the established quality systems requirements and to determine the effectiveness of the Quality Systems, as required by 21 CFR § 820.22.

      View the original warning letter.


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    8. Warning Letter: Failure to validate processes (ucm076566)

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      Failure to validate manufacturing processes and approve according to established procedures, where the results cannot be fully verified by subsequent inspections and tests. [21 C.F.R. 820.75(a)] Specifically: Computer Numerical Control (CNC) Machine #C-4 had out of specification results during operational qualification conducted during validation. These out of specification results were not investigated or addressed in the validation report.

      View the original warning letter.


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    9. Warning Letter: Failure to validate computer software (s6537c)

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      Failure to validate computer software for its intended use according to an established protocol when computers or automated data processing systems are used as part of production or the quality system; as required by 21 CFR 820.70(i). For example: For yours, Asheboro, NC, facility, the [redacted] Training Database software validation used to document employee training was deficient in that the test scripts were not available to show the execution of the software validation protocol. It appears that at least five (5) tests specified in the approved protocol were not performed.”

      View the original warning letter.


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    10. Warning Letter: Employees not adequately trained (ucm076532)

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      Failure to establish procedures for identifying training needs, ensure that all personnel are trained to adequately perform their assigned responsibilities, and document training, as required by 21 CFR 820.25(b). For example: “a. Training records for a sterilizer operator and packager were requested at your Asheboro, NC, facility during the 2007 FDA inspection. Out of five (5) training records requested for the sterilizer operator, only two (2) were available. Two (2) training records were requested for the packager and only one (1) record was available.” “b. A number of documents were collected demonstrating that employees were not adequately trained, at your [redacted] facility.

      View the original warning letter.


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