Finished device model ORI-1401-05 requires installation and testing performed by the user/customer. To ensure that devices are properly installed, the test result are sent to Orion and filed for a record of proper installation. Examining 10-installation test records you notice that 3-test result fall outside the acceptable range.

Batch records for ORI-1505 dated 10-14-XX and 10-20-XX have several production steps that were not “signed-off”.  Additionally, some of the dates are not included on the batch record.

In a batch record the label used was properly included showing the beginning and ending label number. Reviewing the DMR you notice that the current label being used has changed in color and size from the DMR specified label.

Reviewing complaint records you notice that there is a checkbox and signature line to determine whether a complaint constitutes a “reportable event” to the FDA under part 803. In a sample of 15-complaints, none of the complaints have the checkbox or signature fields filled out.

Evaluating the inspection plans for model ORI-2100-01 it is noted that the standard sampling plan, 1 of every 50 units is tested. The design engineer indicates that this is the sampling plan for every model, unless the customer specifies their own plan. Further, regardless of success or failure of a test, the inspector continues to inspect every 50th item.

In finished goods inventory you note that some items have expiry dates (designated as Quarter/Year of expiration). Other items have no expiry date. You notice where items have no expiry date, there is no attempt at stock rotation. You have items on the shelf that are 5-years old and items made last week. All of the last week inventory is placed to facilitate earliest delivery dates (LIFO-method) so customers will not be angry receiving a 5-year old device.

In the label cabinet your notice that all labels for any given product are all stored side-by-side on marked shelves. Sometimes a label can run over its border and mix with the label on either side of it. Looking at model ORI-25001 you notice that every label is identical in color, size and placement of information (all boiler-plate info is the same). However, a model can be purchased in about 6-different model variations.