Regulatory Visits Sample Clauses
Regulatory Visits. Supplier shall notify Company promptly, through its designee, the Company Vice President of Quality, of any inspections by the EMA / FDA or other regulatory authority inspection which pertain to any or Product (s) or facilities that produce Product (s). Supplier will allow the EMA / FDA to inspect, audit and review the facilities and Products are manufactured and all procedures, practices, books, records, and documents to the extent requested by the EMA / FDA. Supplier shall immediately notify Company in writing of any adverse finding or concern relating to inspections by the EMA / FDA, or other regulatory authority including but not limited to, any 483s or other deficiency report related to the Product or facilities which are used for the Product(s). Supplier shall keep Company informed of the resolution of all matters with the EMA / FDA. Supplier and Company shall consult on any corrective actions that relate to the Product. Company retains right to approve any corrective actions that directly affect Company owned Product(s).
Regulatory Visits. Gland shall, within two (2) working days, notify Sagent in the event of any FDA or other regulatory authority inspection regarding Products. In the event of an inspection by the FDA that results in a concern by the FDA specifically related to Product (s), then Sagent through its designee, Sagent will be notified within two (2) business days of such concern. Gland shall furnish to Sagent, not later than five (5) business days prior to the time it provides to the FDA, copies of proposed responses or explanations relating to the Products in each case purged of Confidential Information that is unrelated to the Products. Gland shall allow Sagent the opportunity to review and comment on any proposed response to the FDA and shall consider in good faith any comments proposed by Sagent on the proposed responses. After the filing of a response with the FDA, Gland shall notify Sagent and provide Sagent with copies of any further contacts with the FDA relating to the subject matter of the response.
Regulatory Visits. (a) Alliance shall notify PFC within 24 hours in the event of any FDA or other regulatory authority inspection or query regarding the Product. In the event of an inspection by the FDA or any applicable regulatory authority which results in a concern by the FDA or applicable regulatory authority specifically related to the Product, then PFC through its designee will be notified immediately of such concern. Alliance and PFC shall cooperate in resolving the matter with the FDA or the applicable regulatory authority.
(b) PFC shall notify Alliance within 24 hours in the event of any FDA or other regulatory authority inspection or query regarding the Product. In the event of an inspection by the FDA or any applicable regulatory authority which results in a concern by the FDA or applicable regulatory authority specifically related to the Product, then Alliance through its designee will be notified immediately of such concern. PFC and Alliance shall cooperate in resolving the matter with the FDA or the applicable regulatory authority.
Regulatory Visits. (a) Baxter shall notify PFC within 24 hours in the event of any FDA or other regulatory authority inspection or query regarding the Product. In the event of an inspection by the FDA or any applicable regulatory authority which results in a concern by the FDA or applicable regulatory authority specifically related to the Product, then PFC through its designee will be notified immediately of such concern. Baxter and PFC shall cooperate in resolving the matter with the FDA or the applicable regulatory authority.
(b) PFC shall notify Baxter within 24 hours in the event of any FDA or other regulatory authority inspection or query regarding the Product. In the event of an inspection by the FDA or any applicable regulatory authority which results in a concern by the FDA or applicable regulatory authority specifically related to the Product, then Baxter through its designee, the Baxter Vice President of Quality, will be notified immediately of such concern. PFC and Baxter shall cooperate in resolving the matter with the FDA or the applicable regulatory authority.
Regulatory Visits. In the event of an inspection by the FDA or any applicable regulatory authority which results in a concern by the FDA or applicable regulatory authority specifically related to Products, then OHMEDA PPD through its designee, the OHMEDA PPD Vice President of Quality, will be notified as soon as possible of such concern. GENSIA shall cooperate in resolving the matter with FDA or the applicable regulatory authority.