(b)(4).Manufacturing site evaluation: date of event: unknown.Samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed 1,980 units in the market.There are no units in stock in the warehouse.Received an open and unused sample with the needle detached from the thread and the thread still wound on the pack.Taking into account that no other complaints have been received concerning this issue, for this code batch we consider that this is an isolated unit.Final conclusion: in spite of receiving a defective sample, without a closed samples a suitable analysis cannot be performed.Nevertheless, note of this incident is taken and if any closed sample is received in the future, the case will be re-open and analyzed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.
|