FDA warning letters may have changed the regulatory status of the issues discussed in the letter.FDA is checking to ensure and the company’s corrections are adequate. Matters are described in FDA warning letters and it has been subject to subsequent interaction between FDA and the recipient of the letter.

We are a consulting firm in the Quality Management Systems, Regulatory Affairs, Global Regulatory Submissions (including FDA and European CE Mark) and Compliance (Audit Preparation, Audit Training, Audit Support, Internal Auditing) Space specializing in the medical device space, general manufacturing space, and life sciences space (Bio-medical and Bio-Pharma). For more information visit our website .

https://www.thomasregulatory.com/fda-483-and-warning-letter

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Company- Thomas Regulatory Resolutions, Inc.
Address- Based in Central Florida, USA, near Orlando.
Call us @ +1 (561) 898-0260 (Business Phone)
Email: [email protected]