Warning Letter: Failure to establish procedures (ucm268059)

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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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 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 validate (ucm249221)

You have failed to validate with a high degree of assurance, a process where the results cannot be fully verified by subsequent inspection and test, (21 CFR 820.75(a)). Specifically: You have not validated the preparation of the [redacted] bonding solution which is used to bond the [redacted] subassembly, a component of the Trima ACCEL disposable set; You have not validated the preparation of the [redacted] which is used to bond the [redacted]subassembly and [redacted] subassembly, components of the Spectra disposable sets.

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Warning Letter: Failure to provide validation (ucm253115)

Failure to establish and maintain a design history file (DHF) for each type of device as required by 21 CFR 820.30(j). For example, the following documentation was not present: a) Formal documented reviews of the design results, b) The identification, validation, or where appropriate verification of design changes and, c) The results of the design validation, including identification of the design, date, and individuals performing the evaluation.

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Warning Letter: Failure to provide adequate procedures (ucm242439)

Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example, you have no documentation of “white box” testing of the embedded device software for the Spine Six device as required by your firm’s design control procedure.

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Warning Letter: Incomplete validation (ucm223938)

Your validation procedure describes your acceptance criteria and states [redacted]. However, your validation report does not address [redacted]. In addition, your testing described in your Validation Protocol [redacted] does not account for detection of [redacted]. Your validation data and results should ensure that all your acceptance criteria are met. In addition, your microbiological results provided with your response do not indicate whether the results reflect [redacted].

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Warning Letter: Failure to validate after design changes (ucm217812)

Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before there implementation as required by 21 CFR § 820.30(i). Specifically, your firm’s design change request form and design change review form included with your CSO Design Change procedure (procedure includes no signature and date of approval for implementation and no revision history) does not require validation or verification of design changes before there implementation. Your firm has failed to ensure that after the design requirements are established and approved, changes to the design,
both pre-production and post-production are also validated (or verified where appropriate), and approved before implementation.

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Warning Letter: Incomplete design validation (ucm200389)

Design validation failed to include testing of production units under actual or simulated use conditions as required by 21 C.F.R. 820.30(g). For example, the MedStar System design history records do not include documentation to demonstrate that the physiological data (e.g. blood pressure and heart rate readings) obtained from the patient is the identical data transmitted from the MedStar Collection Server.

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Warning Letter: Faliure of validation process (ucm170224)

Your company did not ensure that its design verification and validation process detected design discrepancies with [redacted] the [redacted] printed circuit board (PCB) of the MTS trial stimulators using the [redacted] components that later caused loss of stimulation, and therefore, failure to complete trial implants.

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