If the observations in the 483 are complex or outside your team’s expertise, consider engaging FAAUZ Pharma consultants who specializes in helping pharmaceutical and biotech companies handle complex regulatory requirements and compliance issues.

Our services include:

• Writing or reviewing FDA responses to align with best practices.
• Auditing facilities, processes, and procedures for continuous improvement.
• Provide adequate Corrective Actions that address the deficiencies noted in the FDA 483.
• Provide Preventive Actions to ensure future compliance.
• Document corrective and preventive actions in your Corrective and Preventive Action (CAPA) quality system.
• Provide customized staff training to improve compliance and reduce the risk of FDA compliance issues.

If you have received an FDA 483 observation or an FDA warning letter, you need to handle the situation with care. The consequences of not addressing Form 483s and warnings can have serious implications for your company. Preventive consultation is an investment that can save your company from the higher costs of receiving a Warning Letter, production interruptions, and potential legal ac