Warning Letter: Failure to establish and maintain procedures for validation (ucm436707)

“Your software development / validation does not include written procedures, structural and regression testing, and code reviews.

4. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). Specifically,

a. Your software development /validation:

1. does not include written procedures covering the development/validation of the software used in your devices
2. documentation for your Evolution Oxygen Conserver device does not include structural testing at the code level (use of static code checkers, independent code review, etc); and
3.  software product testing procedure, Database/Software Controls IQP 030 Rev A dated 10/20/08, does not require structural testing and does not include provisions for the adequate description of regression testing.

….

c. The available clinical studies documentation for the following Evolution Oxygen Conservers:

1. did not include the written protocol or the patient’s baseline saturation levels for the 900M model; and
2. did not include the baseline saturation levels or the device settings for the patients.”

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Warning Letter: Failure to update procedure (ucm466038)

 
“Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b).  For example, your firm completed design change note 798 to modify the moor VMS-LDF device and updated the software from version 1 to version 2.  Work instruction procedure, “[redacted]”, states that version 1 is uploaded onto the device during the main board testing operation.  However, your firm did not update the work instructions to address the software version change.”

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Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

“Failure to establish and maintain procedures to control all documents, as required by 21 CFR
820.40. For example, your firm failed to follow its Documentation Management procedure since it
used electronic signatures to approve numerous procedures. Your firm’s procedure states that
there are no currently-approved electronic signature systems implemented at your firm.”

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Warning Letter: Failure to document digital changes and complaints (ucm421235)

No records of identification, validation or verification, review, or approval were available for design changes to the SimulCare resulting in the SimulCare II. The changes included new digital controls… Failure to ensure that suppliers and contractors were evaluated and selected based upon their ability to meet specified requirements, as required by 21 CFR 820.50(a)(1). Specifically, your firm utilizes various suppliers for components of your devices, including PCBs [Printed Circuit Boards]…your firm failed to record and document investigation of oral complaints related to burnt-out microchips… Specifically, the SimulCare II was cleared under K083202; however, your firm’s promotion of the device provides evidence that the device was modified including a change from analog knobs utilized to control the strength and duration of therapy to digital button controls now utilized for the same function.

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Warning Letter: IQ and OQ for software programs were not documented (ucm428048)

“Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a).

For example, in 2011, the manufacturer of your firm’s Computer Numeric Controlled (CNC) machine LAR 179 installed the machine, its software programs, and produced and tested sample parts. None of the activities related to installation and operational qualification of LAR 179 were documented.”

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Warning Letter: Complaints closed without investigation (ucm42084)

Your firm’s CAPA trending of production hardware failure non-conformances is inadequate in that 39 production hardware failure non-conformances reviewed found you stated a justification for not opening a CAPA for each of these non-conformances as “NCMRs are trended periodically and CAPAs are issued according to this trending.”

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Warning Letter: Failure to perform validation of device software (ucm402449)

Failure to perform validation of device software, as required by 21 CFR § 820.30(g). Specifically, your firm failed to validate the software calculator for the STAAR Visian MICL Lens (ICL models MICL 12.1 mm, MICL 12.6 mm, MICL 13.2 mm, MICL 13.7 mm).

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Warning Letter: Failure to validate software (ucm399525)

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, your firm’s [redacted] Software Operating System used to log, evaluate, and investigate complaints, incoming, in process, and finished non-conformances was not validated to prevent deletions of records by employees.

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Warning Letter: Failure to follow procedures (ucm401361)

The FFDM manufacturer QC (excluding monitor and printer QC) procedures for digital unit 3, Lorad (Hologic), SEL, room Mammography were not followed. [See 21 CFR 900.12(e)(6)]

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Warning Letter: Failure to validate computer software (ucm399523)

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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