Medical Device Manufacturer


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Warning Letter: Failure to validate (ucm249221)

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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)

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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)

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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: Failure to validate computer software (ucm256890)

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Failure to validate computer software for its intended use in production according to established protocol. All software changes shall be validated before approval and issuance. These validation activities and results shall be documented as required by 21 C.F.R. § 820.70(i). For example, your firm failed to validate, according to established procedures, the automated mills and lathes that are used in the manufacturing of components for the PL5 2008 medical laser. Your firm installed [redacted]automated mills and one automated lathe during December, 2006 but your firm could not provide an established validation protocol for the validation of the automated systems or provide any documentation that showed the systems and their controlling software that were used in the manufacture of metal and plastic components of the PL5 Medical Laser were validated. 5. Failure to establish and maintain adequate procedures for validating the device design that includes software validation and risk analysis, where appropriate, as required by 21 C.F.R. § 820.30(g).

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Warning Letter: Validation under operating conditions(ucm239018)

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Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). Your firm failed to perform design validation for the data analysis software used in the Cal Ver EP Evaluator to determine out of specification stability results for Verichem products.

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Warning Letter: Software not validated (ucm239465)

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Failure to validate, for its intended use, computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, your firm has not validated the software used for generating product labels.

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Warning Letter: Software has not been validated (ucm227058)

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The [redacted] Calibration Management software has not been validated as required by 21 CFR 820.70(i). This software is used to maintain equipment calibration records and calibration procedures. This same observation was made during the previous inspection of July 2006.

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Warning Letter: Incomplete validation (ucm223938)

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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 Follow Procedures (ucm216889)

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Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure [21 C.F.R. § 820.75(a)]. “Specifically, the procedure “Validation of the Aseptic Filling Process Utilizing the Media Fill Method,”[redacted], states that initial validations should be conducted consecutively and prior to routine production fills and subsequent re-qualifications should be performed [redacted] as appropriate. In addition, the procedure states that routine production may not resume until acceptable qualification or validation runs are achieved or until all appropriate investigations and/or repeat media fills have been performed with acceptable results. However, validation of the aseptic filling process in filling suite [redacted] for [redacted] bottles was inadequate in that the [redacted] re-qualification of the [redacted] Aseptic Filling Process utilizing the Media Fill Method [redacted]performed on March 23, 2009 failed. The failure produced [redacted] contaminated units out of approximately [redacted] units inspected. In addition, the subsequent validation of [redacted] for filling [redacted]and [redacted] bottle [redacted performed on May 20, 2009 also failed.

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

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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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