Complaint Files Clause Samples
Complaint Files. Supplying Party will maintain written records of Complaints in accordance with cGMPs/QS Regulations, including 21 CFR 820.198, that provide, at a minimum, written records of any investigation and the reasoning used by Supplying Party to determine whether an investigation is, or is not, necessary.
Complaint Files. 17.1 Complaint. The term “Complaint” means any indication of the failure of the Product to meet customer or user expectations for quality or to meet performance specifications, including, without limitation, any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of the Product after it is released for distribution.
Complaint Files. Supplier shall have established a system to record and keep a register of product related complaints. Complaint registers and/or files shall contain all pertinent information related to the complaint including, but not limited to, documented reviews, investigations, and evaluations.
Complaint Files. Javelin and PPS, as applicable, shall maintain complaint files in accordance with Good Manufacturing Practices. [*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.]
Complaint Files. Each of MSI and the Company shall maintain appropriate complaint files relating to the Products manufactured by MSI pursuant to this Agreement and each shall promptly report in writing to the other any complaint related to Product quality.
Complaint Files. Each party shall maintain complaint files relating to the Products.