Warning Letter: Failure to implement SOP (ucm336120)

Specifically, your firm has no standard operating procedures implemented to determine if the complaint received represents an MDR reportable event.  Your firm documents complaints in a computer system called [redacted]; however, this practice is inadequate because you failed to implement a standard operating procedure… Failure to implement procedures to ensure all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.  Specifically, your firm failed to define, document, and implement purchasing control procedures to ensure the Nurse Call hardware purchased from your contract manufacturer conforms to your firm’s specified requirements.

• Failure to establish and maintain adequate procedures to control the design of the device in order to ensure specified design requirements are met, as required by 21 CFR 820.30(a)(1).  For example, your firm failed to establish and maintain written procedures to control the design process, including requirements for design inputs, design outputs, design reviews, design verification/validation, design transfer and design changes for the Nurse Call and Focus devices.

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Warning Letter: Newer Software not validated (ucm340300)

Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example: Your firm’s design validation procedures outlined in Section 4.6 of the Design Control Procedure, Doc. No. [redacted] do not ensure that the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation are documented in the Design History File (DHF). Thirty test records from a clinical study conducted as part of the design validation for the AnyView A8 Monitor were reviewed. The results of the design validation, including the identification of the design, the unit tested, the date, and the individuals performing the validation were not documented. In addition, the investigator noted that a software revision had since occurred; however, your firm admitted that the newer software version had not undergone software validation.

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Warning Letter: Lack of system control (ucm075766)

You failed to establish and maintain process control procedures , including documented instructions and written SOPs for steps in the testing of blood and blood components [21 CFR 606.100(b), 820.70(a)(1)]. Specifically: “a) There are no written procedures describing computer software[redacted] functional requirements or descriptions of functions and there is no computer manual. The database functions as the information management tool used to collect, organize, process, analyze, secure and maintain testing data. “We also note that you have failed to establish an adequate system for authorizing, granting, and rescinding computer access to functions in the [redacted] and adequate computer security provisions to assure data integrity. Current users do not use appropriate access such as passwords and user-id and personnel who have changed jobs still have access to the system.

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Warning Letter: Failure to report significant software changes (ucm339489)

Specifically, the Alcon LenSx Laser System was cleared via K101626, with operating software version 2.02. Your firm has since made multiple revisions to the software, and the LenSx Laser System was running software version 2.13 at the time of the inspection. FDA reviewed your software changes from version 2.02 to version 2.13 and determined that some changes are significant with respect to your original premarket clearance submission and may affect the safety and efficacy of the device. A new 510(k) is required for these changes. … It is your responsibility to report to FDA all significant modifications, including software changes that may change the design or performance and/or affect the safety and efficacy of your devices.

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Warning Letter: No Corrective Action validation plan (ucm332838)

Your firm had not completed any corrective or preventive actions and had not evaluated the effectiveness of your supplier’s corrective actions… E.    Failure Investigation and Corrective/Preventive Action Form No. 497, dated 08/02/2011, stated that DPM Central Station had a software anomaly which caused the trend data for a patient to be replaced by another patient.  On 05/12/2011, your firm released a product correction letter to the field to correct the issue via a software upgrade.  The CAPA effectiveness verification method was identified as verifying that all documents in the corrective action have been modified.  However, your firm was not able to provide any documentation to demonstrate that the CAPA has been verified for effectiveness and that it does not adversely affect the finished device.

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Warning Letter: Computers have not been validated (ucm331623)

• Failure to establish and maintain corrective and preventive action procedures, as required by 21 CFR 820.100(a). For example, there are no written Corrective and Preventive Action procedures.

…

• Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, there are no written complaint procedures.

We reviewed your firm’s response and concluded it was not adequate. Although the response states complaint procedures are being established, there is no indication the software to be installed on the service technicians computers has been validated. In addition, a systemic corrective action is not addressed in your response.

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Warning Letter: No software validation (ucm330805)

Failure to establish and maintain adequate procedures for implementing corrective and preventive action to include requirements for (1) analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary; (2) investigating the cause of nonconformities; (3) identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems; (4) verifying and validating corrective and preventive actions to ensure that the actions do not adversely affect the products; (5) implementing and recording changes necessary to correct and prevent identified quality problems; and (6) disseminating information related to quality problems and nonconforming product, as required by 21 CFR 820.100(a).
For example, review of three out of [redacted] Corrective and Preventive Action (CAPA) records revealed:

a) Q-case #[redacted] concerned [redacted]. Your firm’s investigation identified and processed the corrective actions as a production nonconformance, but statistical methods were not used to quantify the problem. The corrective action of [redacted] was implemented, but validation was not conducted or documented to ensure that the corrective actions was effective and did not adversely affect the product.

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Warning Letter: Inadequate software validation (ucm323748)

The Verification Test for the Programming/Verification of code chips (no document control number) dated 4/21-22/2005 is inadequate in that: i. There is no document control number . ii. Step 6 of the verification test requires a repeat of the step [redacted] times, [redacted] for a total of sample size of [redacted]. Instead, the protocol/raw data indicates only [redacted] blank code chips were utilized to conduct the programming/code chip download challenge (i.e., [redacted] chips for each of the [redacted] code chip types). iii. Upon download of the code chip information, there was no verification activity to ensure that the integrity of the performance data, which is unique to each lot code, was not compromised. iv. The raw data associated with the download challenge/programming of the [redacted] chip is missing from the Programming/Verification of Code Chips documents.

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Warning Letter: Failed to validate computer software (ucm178264)

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).

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Warning Letter: Failure to validate computer software (ucm319510)

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 a quality system, according to established procedure, as required by 21 C.F.R. 820.70(i). For example, there are no procedures that describe the qualification and maintenance of the Sorting software for decay calculations on brachytherapy seeds sorted into inventory. There are no software verification and validation requirements defined in your firm’s procedures, and there are no records documenting that the Sorting software is fully validated for its intended uses.

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