21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been implemented .
21 CFR 820.72(b)(2). Calibration documentation There is no documentation of calibration dates for inspection and measurement and test equipment .
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
No Action Indicated (NAI)
Mar 15, 2012
Devices · Compliance: Devices
16 cited references
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed, maintained, and implemented.
21 CFR 820.181. DMR - not or inadequately maintained A device master record has not been adequately maintained.
21 CFR 820.120. Lack of or inadequate procedures for labeling Procedures to control labeling activities have not been established.
21 CFR 820.160(b). Distribution records Distribution records do not include or refer to the location of required information.
21 CFR 820.120(b). Examination for accuracy Labeling was not sufficiently examined by a designated individual for accuracy including before release.
21 CFR 820.120(d). Records, DHR {see also 820.184(e)} Labels and labeling used for each finished product, lot, or batch, were not sufficiently documented in the DHR.
21 CFR 820.70(b). Production and Process Change Procedures, lack of or Inad. Procedures for changes to a method and process have not been established.
21 CFR 820.184. Lack of or inadequate DHR procedures Procedures for device history records have not been established.
21 CFR 820.120(a). Remain legible Labels were not printed so as to remain during processing, storage, handling, distribution, and/or use.
21 CFR 820.70(a). Process control procedures, Lack of or inadequate procedures Process control procedures that describe any process controls necessary to ensure conformance to specifications have not been established.
FDCA 501(a). Medical Device Field Exam During a field examination of medical device products at your facility the following was observed:
21 CFR 820.198(a). Lack of or inadequate complaint procedures Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established.
21 CFR 820.75(c). Process changes - review, evaluation and revalidation A validated process was not reviewed and evaluated and revalidated when changes or process deviations occurred.
21 CFR 820.22. Quality Audit/Reaudit - conducted Quality audits have not been performed.
21 CFR 820.20(b). Lack of or inadequate organizational structure The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
21 CFR 820.70(e). Contamination control, Lack of or inadequate procedures Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been established.
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