Warning Letter: Failure to provide validation documentation (ucm293443)

Failure to validate computer software used as a part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm could not provide any documentation to demonstrate that the software used for the 6111 PCB (Printed Circuit Board) check machine [redacted] was validated for its intended use. Your firm’s Department Manager of Regulatory Affairs stated that the software used for the PCB check machine has not been validated.

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Warning Letter: Failure to establish procedures (ucm279058)

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).

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Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example: Your firm does not have a purchasing control procedure and has not evaluated the contract manufacturer to ensure that manufacturing processes are appropriately validated. In addition, there are no maintenance procedures in place, nor has your firm established procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

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Warning Letter: Failure to exercise appropriate controls (ucm279058)

Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 CFR 211.68(b)]. For example: a. Your firm did not put in place requirements for appropriate usernames and passwords to allow appropriate control over data collected by your firm’s computerized systems including UV, IR, HPLC, and GC instruments. All employees in your firm used the same usemame and password. In addition, you did not document the changes made to the software or data stored by the instrument systems. Without proper documentation, you have no assurance of the integrity of the data or the functionality of the software used to determine test results. b. Your firm had no system in place to ensure appropriate backup of electronic raw data and no standard procedure for naming and saving data for retrieval at a later date. In your response, you state that you will maintain backup of electronic raw data and all technicians will have their own user identification (ID) and password.

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Warning Letter: No contols over computer system (ucm278262)

Your firm has failed to exercise appropriate controls over computer or related systems to assure that the input to and output from the computer or related systems of formulas, other records, or data, are checked for accuracy [21 C.F.R. § 211.68(b)]. For example, your firm’s custom software for your Master Batch Production record, referred to as the “I-131 Database,” has not been validated. This software is responsible for generating the batch production record, performing calculations to produce varying concentrations of drug product, and generating label information for customer vials and lead pigs.

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Warning Letter: Failure to establish procedures (ucm279180)

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). For example: the device design was revised to include an [redacted] for both the ActiveCare DVT and ActiveCare+SFT devices. Your firm’s design validation report No.71365539, Safety Technical Report OVP, includes design verification test results where the device was tested at [redacted] but does not appear to include testing of production units under actual or simulated conditions as indicated in your Design Verification and Validation procedure referenced in your Design Changes Procedure.

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Warning Letter: Inadequate records (ucm271583)

Failure to maintain adequate drug disposition records raises concerns about subject safety and data integrity. We acknowledge that your written response states that upon your discovery of both the lack of drug accountability and the missing vials, pharmacy and research SOPs were evaluated and revised; and that future studies at your site will be conducted under the umbrella of US Oncology Research, which has an electronic drug accountability system. However, as the clinical investigator, it was your responsibility to ensure that adequate records of the disposition of the drug were maintained; and US Oncology Research’s policies, procedures, and activities do not negate your responsibility as the clinical investigator.

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Warning Letter: Failed to exercise appropriate controls (ucm270668)

Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].  For example, your firm has failed to periodically conduct back-up procedures for the [redacted] Server, Equipment [redacted] (Building [redacted], Room [redacted]) since August 2010. This server was used to store, back-up, and/or archive raw test data from computer systems (Software:[redacted]controlling and monitoring [redacted] High-performance liquid chromatography (HPLC) systems in accordance to SOP, [redacted]titled, [redacted].” During the inspection, the [redacted]server was observed as being tagged out-of-service since February 2009.

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Warning Letter: Failure to establish adequate procedures(ucm271368)

Failure to establish adequate procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, testing records for timers received on March 27, 2009; April 9, 2009; April 17, 2009; and May 28, 2009, only included a computer printout of the final data as the original raw data of the testing conducted and acceptance data for each of the timers were not maintained.

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Warning Letter: Failure to establish validation procedures (ucm268244)

Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to ensure proper risk analysis is completed; and to ensure the results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation are documented in the design history file, as required by 21 CFR 820.30(g). Specifically, Validation of device software was not performed.

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Warning Letter: Failure to establish procedures (ucm268059)

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1). For example: You do not have design control procedures. You also have no documentation of design validation or design change controls for the Antalgic-Trak, including no documentation of risk analysis or structural [redacted] testing of the embedded software.

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