Complaint - What is the FDA's definition?

The FDA definition is:

i Complaint means any written, electronic, or oral communication
that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it
is released for distribution.[/i]

The “alledges deficiencies” is the part I am having a problem with. I am looking for others opionions.

What is your concern? If a customer alleges your device is broken because it doesn’t turn on, it’s a potential deficiency until you investigate & find out he put the batteries in upside down. (Here though, maybe your instructions are insufficient and caused the user to put the batteries in upside down!) I think it allows the manufacturer the benefit of determining whether or not the complaint is a deficiency or not.

Thanks Vodon

Any verbal or written communication received directly from any Regulatory authority, customer, retailer, distributor, physician pharmacist, patient (Consumer) or field staff, regarding the purity, efficacy, side effect, labeling / packaging defects, shortages or any other such Complaints shall be considered as a Market Complaints.


Satish Thube