Warning Letter: Hospital stretcher manufacturer failed to validate computer software (ucm 355751)

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). Specifically, [redacted], developed by [redacted], is used to transfer and make changes to drawings used to manufacture devices. There is no protocol or documentation demonstrating that this software has been validated for its intended use.

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Warning Letter: Failed to exercise appropriate controls (ucm 355294)

Additionally, during an audit of the data submitted in support of the [redacted] regarding [redacted] tablets USP [redacted] mg, our investigator requested to review the electronic analytical raw data to compare the values for [redacted] assay and degradation products. However, your firm provided only the printed copies of the raw data because your firm did not have the software program available to view the electronic raw data.
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)).

During the inspection, our investigator also identified a backdated QC worksheet in the analytical report of [redacted] API raw material batch [redacted]. When your analyst affixed the related substance and IR weight printouts to the Format for Blank Sheet for Printout (Format No. F2/QCD/F/026-00), he signed and dated this worksheet as July 29, 2011. A second analyst, who reviewed this worksheet, also signed and dated it as July 29, 2011. However, your QA department did not issue this worksheet until July 31, 2011. Your analyst acknowledged during the inspection that he backdated this worksheet on July 31, 2011.

Your response stated that the analyst incorrectly dated the worksheet as July 29, 2011, instead of July 31, 2011, and that there was no intention to deliberately backdate the document. However, your response contradicted your analyst’s backdating admittance during the inspection. In addition, your response did not explain the reviewer’s signature which was also dated July 29, 2011.
Backdating documents is an unacceptable practice and raises doubt about the validity of your firm’s records.
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Warning Letter: Failure to implement software upgrade (ucm 352318)

CAPA [redacted] was opened on May 25, 2011 to address Plum A+ pump battery failures which can cause a delay or interruption of critical therapy. Your firm has failed to  implement the identified corrective actions in this CAPA, such as a software upgrade to change the risk profile; battery replacement to reduce the probability of occurrence; battery supplier approval with increased controls; and notification to customers, despite the fact that your firm has received 311 complaints for code E321 documenting battery failures and 11 MDRs documenting a stoppage of critical drug delivery as of January 31, 2013. Plum A+ infusion pump: Review of the “analysis” data field for Plum A+ complaints revealed failures of the bubble sensor printed wire assembly within the printed circuit board, battery, touch key pad assembly and front case assembly.

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In addition, the failed components are not identified as a data source for analysis nor are they trended in your CAPA system to assess whether a preventive or corrective action is indicated and to ensure that components are performing according to infusion pump design specifications.

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Warning Letter: Failure to document changes (ucm 348651)

During our inspection, a Red Blood Cell component was identified as being in quarantine according to an electronic inventory inquiry on January 30, 2013. However, the component could not be located in the expected physical quarantine location. After the discrepancy was identified by our investigators, a search was initiated and the component was found in the discard bin. The component had been physically discarded without maintaining a record of the discard as required by TS 500-2, Final Disposition of Blood Components. Failure to check input to and output from the computer or related system of formulas or other records or data for accuracy [21 CFR 211.68(b)].

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Warning Letter: Labeling software is not defined in SOP (ucm 352769)

Your firm’s product labeling procedure has not been adequately implemented as required by 21 CFR § 820.120. Specifically, you lack documented approval for your vacuum therapy device; labeling software is not defined in your standard operation procedure; and device history records lack the primary label/labeling.

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Warning Letter: eCRF lacks laboratory values (ucm340269)

As an investigator, you are responsible for maintaining accurate, complete, and current records relating to the investigation. (See 21 CFR 812.140(a)). You failed to adhere to the above-stated regulations. Examples of these failures include, but are not limited to the following: a. (b)(6) • The Electronic Case Report Form (eCRF) lacks baseline vital signs, permanent pacemaker) interrogation findings, or laboratory values.

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Warning Letter: Failure to follow procedure (ucm342736)

Failure to establish and maintain adequate procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example, the design control procedure (P03 02) requires that design reviews be completed at the end of the completion of all technical documentation. The design review for the Lady Comp device was completed June 16, 2008, prior to the completion of the software qualification for the Lady Comp device, which was completed October 17, 2008. No design review was conducted after the software qualification. The adequacy of your firm’s response, dated October 26, 2012, cannot be determined at this time. Your firm completed a new design review for the Lady Comp device that included software validation. Additionally, your firm stated that training would be conducted on the current design review procedure. However, the evidence of implementation to include the training documentation was not provided in the response.

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Warning Letter: Failure to have procedures (ucm342647)

We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following: 1. Failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a).

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Your supplier, which was used to fill ampoules was disqualified for this service due to quality issues , but was left on your approved suppliers list because the supplier is still approved for other services. The supplier remained on the approved supplier list for all products, and/or services. There is no method for disqualifying suppliers from providing specific products and/or services. The response dated January 7, 2013 cannot be assessed at this time. Your response states that all supplier evaluation and control procedures will be revised to include an appropriate mechanism to ensure suppliers are qualified and disqualified on a product or service-specific basis. These procedures will also be reviewed to assure compliance with the Quality System Regulation . Additionally, you will also electronically prevent the issuance of purchase orders unless a supplier is approved for a specific product or service.

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Warning letter: Failure to validate (ucm337808)

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 uses custom automatic machines in the needle production process. Your firm stated that it performed software validation for the automatic machines and that the software protocol was tested, but these validation activities were not documented.

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Warning Letter: Failure to validate computer software (ucm340155)

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: There is no evidence that validation was completed for the [redacted] software used by your firm to provide the customer with the graphic representation of the flow rate of the device. [redacted], indicated that your firm did not have user requirements, input, or output requirements for the [redacted] software.

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