The sample was not returned for review and the information provided is limited.
Additional information has been requested.
A review of the manufacturing records was performed and found that the lot was manufactured to specification.
No manufacturing issues associated to the alleged incorrect packaging were found in the reviewed lot.
To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in february 2019.
At this time, there is no identification of a problem with the device, however no definitive conclusion can be made as to the cause of the problem reported.
Should additional information be provided, a supplemental emdr will be submitted.
|