Warning Letter: Failure to establish procedures (ucm224014)

Failure to establish and maintain adequate procedures for verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example, no protocol, including acceptance criteria, was established for the validation of Change Request [redacted]. Additionally, there was no documentation showing that this change was validated.

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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 Follow Procedures (ucm216889)

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)

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: Failure to validate software (ucm215449)

In addition, FDA noted nonconformance with regards to section 501(h) of the Act, 21 U.S.C. 351(h), due to deficiencies of the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at 21 C.F.R. Part at 21 C.F.R. Part 820. These deviations include, but are not limited to, the following:

• Failure to validate the device software for the RTVue OCT with NDB, software versions 3.5 and 4.0 as required by 21 CFR 820.30(g). Specifically: “a. Software 3.5 Version C, was tested between [redacted]. The test result shows a failure with sequence [redacted]. The failure was identified as [redacted], unreasonable video baseline, known “bug”.
• Verification and Validation for Version D was approved on [redacted] to address the test result identified from the testing of software Version Verification and Validation testing was performed on software 3.5 Version D, on [redacted]. The report identifies a “Remaining Defect List” and Number [redacted] is identified as “Critical”, “Spectrometer Motor Error!” This software version was released on [redacted] without addressing defect number [redacted] and without supporting documentation software defect number [redacted] was corrected.
• Verification and Validation test results/raw data for software 4.0, Version B, were performed on [redacted] and [redacted]. Sections of the test data were not performed, unsigned, and/or missing as follows: I. Section 16 – Cornea Module, not performed. II. Section 11 – Gridline Examine and Analyze, not performed. III. Section 10.2 – Verify [redacted] new function, unsigned and undated. IV. Section 15 – Combined Progression of [redacted] and [redacted] scans, a test sequence was not performed. V. Unidentified Section, raw test data missing. This test section is signed-off by an employee, with a completion date of [redacted].
•  Electronic sign-off copy of the Verification and Validation Report for software 4.0, Version B. found the following: I. Section 16 – all sequence is entered as pass without supporting data to demonstrate the test was performed. II. Section 11 – all sequence entered as pass without supporting data to demonstrate the test was performed. III. Section 10.2 – contains an electronic signature of an employee, dated [redacted] IV. Section 15 – all sequence entered as pass without supporting data to demonstrate the test was performed. V. Section 3.1 – Verify Calibration Data is entered as being completed on [redacted] There is no supporting data to demonstrate sequence testing was performed. However, the last sequence test page of this test section is identical to a test performed by an employee on [redacted], not [redacted] as entered into the firm’s electronic sign-off copy.
• Verification and Validation report for software version 2.0 is not available for review. According to your employee, once the results are entered into your electronic report, the raw tests data are discarded. Therefore, you have no evidence the sequence testing was performed.

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Warning Letter: Failed to validate input/output (ucm214564)

Your firm failed to check the accuracy of the input to and output from the computer or related systems of formulas or other records or data and establish the degree and frequency of input/output verifications. For example, the performance qualification of your [redacted] system software (Validation No. 4000-03-PQ-0002) failed to include verification of the expiration date calculations in the [redacted] system. In addition, there is no established degree and frequency of performing the verification. Discrepancy reports have documented that product labeling with incorrect expiration dates have been created and issued for use.

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Warning Letter: Failure to document validation (ucm201895)

Failure to maintain a design history file for the “Defender” air filtration system, as required by 21 CFR § 820.300). Specifically, your firm  could not locate the design inputs, outputs, verification and validation documents, design reviews and design changes for the “Defender”.

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Warning Letter: Failure to validate CAPA proedures (ucm201897)

Your firm’s Corrective and Preventive Action Practice form does not specify that you will verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device as required by 21 CFR § 820.100(a)(4). For example, your firm needs to perform effectiveness checks in order to verify that the corrective and preventive actions were effective  as to the intended purpose of the action and that new issues or concerns are not introduced.
Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation as required by 21 CFR § 820.30(i). Specifically, your firm has failed to establish and maintain design control procedures for the design changes that were made to your devices during the months of May and June of 2009.

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Warning Letter: Failure of adequate controls (ucm200384)

Failure to have adequate controls to prevent manipulation of raw data during routine analytical testing. “For example, your firm’s laboratory analyst had modified printed raw data related to the IR Spectra test of [redacted] and [redacted]. We are concerned that the lack of security or system controls allows for this practice.

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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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