Warning Letter: Failure to maintain quality system requirements (ucm152423)

Failure to establish and maintain an adequate organizational structure to assure that quality system requirements are fully met, as required by 21 C.F.R. § 820.20(b). For example, your Quality Assurance Department consists of one individual, the Quality Manager, who is responsible for implementation of your CAPA system, quality audits, document control, training, developing procedures, conducting process validations, and all other aspects of your quality system for both medical and non-medical products. During the inspection your quality manager stated that he lacked sufficient time and resources to complete many of the Quality System requirements. Additionally, you stated that your quality system has not kept pace with the growth of your firm’s business.

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Warning Letter: Failure establish and maintain records (ucm166530)

Failure to evaluate and select suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements, as required by 21 C.F.R. 820.50(a)(1). 17) Failure to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 C.F.R. 820.50(a)(3).

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Warning Letter: Lack of validation testing (s6906c)

Your validation of your device design is incomplete in that the firm has not established a protocol for conducting validation testing and did not validate the software to ensure that devices conform to the defined user needs and intended uses, as required by 21 CFR §820.30(g). Specifically, you have made 1,900 revisions to the software in three years without conducting validation testing .

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Warning Letter: Failure to maintain procedures, documentation (s6881c)

Failure to establish and maintain adequate 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).

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Warning Letter: Failure to Comply (s6876c)

• Failure to adequately validate manufacturing processes with a high degree of assurance, and approve and document the results of the validation activities, to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(a). Specifically, your firm has not validated the milling process and documented the validation results to ensure that the brass rounds are correctly milled to patients’ programmed [redacted] files [redacted] codes).
• Failure to revalidate manufacturing processes in response to changes or process deviations, and document the results of the revalidation activities to ensure that product specifications can be consistently met, as required by 21 C.F.R. § 820.75(c). Specifically, your firm has not documented the results of the revalidation of the milling process after your firm repaired a loosened bushing on the tooling plate and [redacted] without established procedures in place for implementing these changes.
• Failure to establish and maintain procedures for verifying or validating, approving, and documenting changes to a specification, method, process, or procedure, before implementation, as required by 21 C.F.R. § 820.70(b). Specifically, your firm has not established written procedures describing how changes to your milling process are to be verified or validated, approved, and documented.

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Warning Letter: Failure to maintain validation documentation (s6847c)

“Specifically, your firm has not conducted quality audits and established adequate procedures for … acceptance activities and computer software validation … your firm has not established written procedures describing how it evaluates, verifies or validates, documents, and approves design changes. Failure to validate software used as part of production and quality system for its intended use according to an established protocol, and failure to document the results of the software validation, as required by 21 C.F.R. § 820.70(i). FDA 483 Item 8. Specifically, your firm has not maintained documentation of the validation of the computer software used to (a) receive encrypted patient treatment data and decrypt/encrypt it; (b) convert decrypted patient treatment data into […] codes that are converted into […] codes that are then sent to your contract manufacturer’s […] milling machine to produce the compensators.”

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Warning Letter: Failure to provide validation plans and reports (s6845c)

“you have not provided verification and validation data to demonstrate the software revision will be effective over the life of the device. In your response to this warning letter, please provide the verification and validation plans and reports for Software [redacted]”

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Warning Letter: Failure to establish procedures (s6788c)

Failure to establish design change control procedures for the identification, documentation, validation and/or verification, review, and approval of design changes before implementation. [21 CFR § 820.30(i)] Specifically, between 2003 and 2006, design changes were made to the Secure Safety Insert System. The molding operation was changed to improve the visibility of the biohazard symbol on the cap; the interlock of the cap into the tube was changed to improve the pull strength testing; and short caps were added to accommodate different size syringes.  Verifications and/or validations, design reviews, design releases, and design approvals were not performed for any of these changes.

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Warning Letter: Failure to provide documentation of validaiton (s6786c)

“Failure to establish and maintain procedures for validating the device design, including software validation , as required by 21 CFR 820.30(g). For example, your firm provided no documentation of validation of the embedded software in the SAFERsleep device.”

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Warning Letter: Failure to establish and maintain adequate procedures (s6752c)

Failure to establish and maintain adequate procedures for validating the device design to include software validation and risk analysis, as required by 21 CFR 820.30(g). For example, [redacted] Software Development Manager, indicated the diagnostic algorithm system for the PAD software was enhanced to version [redacted] from [redacted] in September 2007, to include the Arabic and Persian languages. The pediatric capability transfer for the PAD device was conducted on 1/18/07, and 2/19/07. Your validation protocol ( [redacted]) failed to document how you validated the software upgrade or how you validated the pediatric capability transfer. 2. Failure to establish and maintain adequate procedures for acceptance of incoming product to include inspection, testing, or other verification as conforming to specified requirements, as required by 21 CFR 820.80(b). For example: a) The Heartsine Samaritan AED System Traveler form ( [redacted]) indicates that Internal Inspection and In QAT testing was not performed for serial numbers [redacted] and [redacted]. Additionally, the required Monitoring Mode for steps [redacted] through [redacted] was not performed for serial number [redacted] b) The Heartsine Samaritan PAD Unit [redacted] form ( [redacted]) indicates that Internal Inspection and In QAT testing was not performed for serial number [redacted] c) The Heartsine Samaritan PAD [redacted] Page ( [redacted]) indicates that [redacted] Inspection and Inspection of [redacted] were not performed for serial numbers [redacted] and [redacted]”

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