Medical Device Manufacturer


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Warning Letter: No audit trail, data cannot be verified (s6736c)

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All study data are handled and controlled by your Study Coordinator, who enters the data into an electronic data base. There is no audit trail or log of data changes that are made to the information in the database. Data cannot be verified against source records, since such records are not maintained.”

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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.

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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).

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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).

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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.

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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.

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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.

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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.”

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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.

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Warning Letter: Failure to maintain records (s6526c)

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Failure to maintain accurate, complete, and current records of each subject’s case history and exposure to the device [21 CFR 812.140(a)(3)].” “We also note that according to Ms. Little-Tierney, all of the original medical records involved in this study were discarded after they were scanned. Your response to the FDA 483 indicates that your medical practice normally operates as a [redacted] office, relying on [redacted] copies of records. Any [redacted] records you maintain must be sufficient to meet your underlying recordkeeping obligations. As we noted above, as an investigator, you are required to maintain accurate, complete, and current records as provided for in 21 CFR 812.140 (a). You must maintain all required records for a period of two years after the latter of the following two dates: the date on which the investigation is terminated or completed, or the date that the records were no longer required for purposes of supporting a premarket approval application or a notice of completion of a product development protocol. (See 21 CFR 812.140(d)).

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