VALIDATION SOP.
Recent Warning Letter Content 1. In our free validation SOP. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of Part 820 and the manufacturer's established quality policy and objectives, as required by 21 CFR 820.20(c). Specifically, there is no evidence that management reviews have been conducted. [See inspectional observation 2.] 2. Failure to establish procedures for, and to conduct, quality audits to assure that your firm's quality system is in compliance with the established quality system requirements, and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Specifically, there is no evidence that you have established quality audit procedures or that quality audits have been performed. [See inspectional observation 3.] 3. Failure to ensure that personnel are adequately trained to perform their assigned functions and to document training, as required by 21 CFR 820.25(b). Specifically, employees involved in the manufacturing, packaging, testing, shipping, and complaint handling of in vitro reagents have not been trained in current Good Manufacturing Practice or the QS regulation, and you were able to provide documentation of any type of training for only one of your current employees. [See inspectional observation 18.] 4. Failure to establish and follow document approval, distribution and change procedures, as required by 21 CFR 820.40. For example, procedures on how to control approval, distribution, and changes to device master records (DMRs), specifications, device history records (DHRs) and labeling for your strep A and hCG in vitro diagnostics were not available and documents not signed as approved for use were being used in product manufacturing and finished product testing locations during this inspection. [See inspectional observations 16 and 17.] 5. Failure to establish 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, quality requirements to be met by your contract manufacturer of your strep A and hCG in vitro diagnostics have not been defined or documented. [See inspectional observation 5.] 7. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72 (a). Your firm has no procedures to ensure that equipment is routinely calibrated, inspected, checked and maintained. For example, procedures for calibration, inspection, checks and maintenance of your firm's digital scales, autoclave and spectrophotometer used in the manufacture and testing of your strep A and hCG in vitro diagnostics were not available. [See inspectional observation 11.] 8. Failure to validate with a high degree of assurance and approve according to established procedures a process whose results cannot be fully verified by subsequent inspection and test, and failure to document such validation activities and results, as required by 21 CFR 820.75(a). For example, there is no documentation of validation of your firm's manufacturing process, cleaning operations, software calculations or filling operations for your strep A and hCG in vitro diagnostics. [See inspectional observation 9.] 9. Failure to document that incoming product has been inspected, tested, or otherwise verified as conforming to specified requirements, as required by 21 CFR 820.80(b). For example, there is no documentation of acceptance activities for incoming reagents, reagent bottles, bottle droppers, bottle caps, or labeling for your strep A and hCG in vitro diagnostics. [See inspectional observation 13.] 10. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, and to hold finished devices in quarantine until all activities required by the DMR are completed, as required by 21 CFR 820.80(d). Specifically, entire lots of your strep A and hCG in vitro diagnostics were tested and released after the first day of assembly/production before all activities required in the DMR had been completed. For example, the following lots were released prior to completion of all activities required in the DMR: Mainline Confirms Strep A, lot 94610; Mainline confirms DOTS Strep A, lot 92720; Mainline confirms III hCG serum/urine, lot 96380 and Mainline Maxie pregnancy test urine hCG, lot 418F30. [See inspectional observation 7.] 11. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. Specifically, no corrective and preventive action procedures were available during this inspection. [See inspectional observation 15.] 12. Failure to establish and maintain procedures to control labeling activities to assure that a designated individual has examined labeling for accuracy including, where applicable, the correct expiration date, control number, storage instructions, handling instructions, and any additional processing instructions prior to labeling release for storage or use, as required by 21 CFR 820.120(b). For example, the DHR does not include a date or signature of a person who examined and approved the expiration date and lot numbers on your labels for your Strep A and hCG in vitro diagnostics. [See inspection observation 10.] 13. Failure to document the label and labeling used for each production lot in the device history record, as required by 21 CFR 820.120(d). For example, the lot code and expiration labeling for the Strep A and hCG pregnancy screening test kits are not recorded in the DHRs. [See inspectional observation 8.] 15. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). For example, you have failed to provide a DHF for any of the devices that your firm manufactures. [See inspectional observation 12.] 16. Failure to maintain complaint files, and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, you stated that you stopped documenting complaints over a year ago, and there is no evidence that complaints 02-05-037, 02-06-004 and 02- 6-023 were reviewed or evaluated. [See inspectional observation 4.] |