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: No Procedures for Controlling Worksheets (ucm218221)

Your firm has no procedures for controlling laboratory worksheets including changes to worksheets, issuance of laboratory worksheets, and reconciliation of laboratory worksheets. The worksheet “Internal Communication – Batch Release Information” by the warehouse, which is used to identify released product, was created after [redacted] documented release of finished product for Heparin I.V. Flush Syringes and Normal Saline I.V. Flush Syringes prior to obtaining media fill results. This sheet is used to communicate batch release information to warehouse operations. Use of this sheet is not documented in any Medefil procedure nor is control over this sheet documented.

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Warning Letter: Failure to establish procedures (ucm216937)

Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm opened CAPAs in response to quality audit data which showed the lack of QS regulation training in many departments within your firm. However, the CAPAs do not contain or reference documentation to support complete implementation of the CAPA activities, such as investigating the cause of the nonconformity, identifying the action needed to correct and prevent recurrence, and verification or validation of the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as defined in your firm’s Corrective & Preventive Action Procedure QSR-115.

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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 to maintain adequate procedures (ucm200878)

Failure to establish and maintain adequate procedures to identify all the action(s) needed to correct and prevent the recurrence of nonconforming products and other quality problems, as required by 21 CFR 820.100(a)(3). For example: You have decided to issue a software update as a corrective measure for resistor related issues. However, our review indicates that the latest software update is only a method of detection and will not prevent resistor failures.  “Failure to review and evaluate all complaints to determine whether an investigation is necessary and maintain a record that includes the reason when no investigation was made, as required by 21 CFR 820.198(b).

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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: Failure to Automate Data Processing Systems (ucm190816)

You have failed 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 the production or the quality system, as required by 21 CFR 820.70(i). Specifically, there is no record of validation for software in the [redacted] which is used to make components for the aspirating dental injection syringes.

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Warning Letter: Failure to Validate Spreadsheets (ucm185865)

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, when requested, no validation information or protocols were provided for the [redacted] software which is used for product complaints, CAPA requests/actions, preventive action request/actions, and creating quality logs.

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Warning Letter: Failure to validate off-the-shelf software (ucm185181)

Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses off-the-shelf software that generates the labels for the dental alloys. The off-the-shelf software has not been validated for this use.

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