Common use of Production Controls Clause in Contracts

Production Controls. 13.1. Flextronics shall have in place and maintain a quality system that meets the applicable requirements of ISO 13485:2003, FDA Quality System Regulations (21 CFR 820)for the production of the Product. 13.2. Flextronics shall have in place and maintain environmental controls meeting the applicable process control requirements of ISO 13485:2003 and FDA Quality System Regulation (21CFR820.70(c)), and applicable sections of ▇▇ ▇▇▇ ▇▇▇, and subpart C, Buildings and Facilities, for the production of the Product. 13.3. Flextronics shall inform Alimera a minimum of [****] in advance unless otherwise agreed, of any change that impacts Product specifications. This includes changes to approved suppliers for Materials that are part of any Product Specifications. Flextronics shall obtain written approval from Alimera for any changes prior to implementation of changes.