Retired FDA Investigator & Compliance Officer
Timothy Couzins
Known for resolving FD-483, Warning Letter and Consent Decree matters by interacting directly with the Agency on a firm's behalf.
- Compliance
- FD-483
- Warning Letter
- cGMP
30+ years FDA and industry
Background
Tim Couzins is a retired FDA Investigator and Compliance Officer with more than 30 years of combined FDA and industry experience. He is well versed in pharmaceutical and medical device regulatory and GMP requirements, and has implemented high-quality, compliant systems in operating companies.
Tim is known for his skill in resolving FD-483, Warning Letter and Consent Decree issues, including interacting directly with the FDA on a firm's behalf — the compliance-officer perspective on what an adequate response actually looks like.
What Timothy does on an engagement
- FD-483 and Warning Letter response strategy and drafting
- Consent Decree remediation and commitment tracking
- Direct FDA interaction and meeting representation
- GMP quality system implementation
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