Warning Letter: Failure to have computerized systems with sufficient controls (ucm484910)

” Failure to have computerized systems with sufficient controls to prevent unauthorized access or changes to data.

During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards.
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Warning Letter: Lack of Audit Trails and other deficient computerized system controls (ucm478393)

“Your firm failed to establish appropriate controls over computers and 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)).

You lacked audit trails or other sufficient controls to facilitate traceability of the individuals who access each of the programmable logic controller (PLC) levels or Man-Machine Interface (MMI) equipment. You had no way to verify that individuals have not changed, adjusted, or modified equipment operation parameters.”

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Warning Letter: Electronic files not properly validated or maintained (ucm178453)

During the FDA inspection it was discovered that electronic records are used to establish the firm?s Complaint Files, 21 CFR 820.198. However there is no documentation to establish that these electronic records meet the requirements of 21 CFR Part 11, Electronic Records; Electronic Signatures. The requirements of 21 CFR Part 11 are designed to ensure that electronic records are trustworthy, reliable, and generally equivalent to paper records.

For example, review of your electronic complaint files reveals they have not been properly validated there is no ability to generate accurate and complete copies of records in human readable and electronic form, there is no protection of records] to enable their accurate and ready retrieval, access to your system has not been limited, as well as other significant deficiencies.

We strongly encourage you to perform a thorough and complete evaluation of all your electronic records in accordance with 21 CFR Part 11 as well as any guidance generated by FDA to assure conformance to our requirements.

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