FDA Warning Letter Management for Pharmaceutical Companies

Regulatory Compliance Associates® Inc. has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. We know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. We can develop a comprehensive proof book of documented objective evidence demonstrating the corrective actions taken to remediate non-compliant issues. In addition, RCA can help prepare a comprehensive strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

Our Pharmaceutical Remediation Strategy & Support services are organized to help you deal with circumstances as they unfold. We help you to understand the broad implications of your specific situation and layout a remediation strategy acceptable to the regulatory agency. We can partner with you to manage plan execution and to help you stay in a compliant state going forward. Representative services we offer include:

 

21 CFR part 210 and 211 Remediation

Continued compliance to 21 CFR part 210 and 211 — including current good manufacturing practice (cGMP) — is crucial in the pharmaceutical industry. cGMP compliance is especially vital if you’re looking to receive an FDA Certificate of Pharmaceutical Product.

RCA is here to help you improve your adherence to cGMP and CFR part 210 and 211 if you’ve received a compliance violation. We’ll help you develop strategies to maintain this critical compliance through our remediation services, including:

 

  • Complaints review and assessment
  • Laboratory operation improvements
  • Supplier quality programs and agreements
  • Investigations/CAPAs improvements

Regulatory Action

At RCA, we understand the significant challenges that your business faces after receiving a warning letter from a regulatory agency. Our experts will develop a customized, comprehensive plan to address regulatory issues following a:

 

  • FDA Form 483
  • Warning letter
  • Consent decree

Oversight Services

When you need to remediate quality systems and manufacturing operations, we offer services designed to evaluate problem areas, determine a plan of action and provide assistance after implementation to ensure continued compliance. These oversight services include:

 

  • Auditing services to check for compliance gaps
  • Creating an action plan for cGMP areas
  • Improve manufacturing production practices and quality control

Data Integrity

Properly handling your pharmaceutical company’s data is vital, and we provide a host of training and consulting services that will help you manage data integrity and target any notable issues. These services include:

 

  • Training opportunities such as corrective action and preventive action (CAPA), good manufacturing practice (GMP), good documentation practice (GDP) and investigations
  • Consulting services like audits and development and implementation of a post-audit remediation plan

Manufacturing and Facility Support

Whether you’re installing new manufacturing equipment or face operations and equipment compliance challenges, we offer validation programs tailored to meet the needs of your organization. Our manufacturing and facility support services include:

 

  • Validation of equipment, facilities and utilities
  • Re-validation of old equipment
  • Remediation of quality system deficiencies

Part 11 and Computerized System Validation

Our team of engineers and computer validation professionals is well-versed in the GAMP4 validation model and can support the validation of a range of systems following a compliance challenge, including:

 

  • Network infrastructure
  • Laboratory systems
  • Control systems and automation
  • Custom software

Laboratory Support

If you’ve recently received a 483 or warning letter — or if you’re starting to return to a normal state of business following a compliance crisis — your compliance of laboratory operations with cGMP is exceedingly crucial. We offer many laboratory support services designed to keep your laboratory in compliance with industry regulations, such as:

 

  • Data integrity verification
  • On-site inspections
  • Risk assessments
  • Method development assessments

Contact RCA for Remediation Strategy and Support Services

At RCA, we know just how profoundly a compliance crisis can affect your business and morale, which is why we offer an extensive range of remediation resources, support and solutions customized to your business’ unique compliance situation. We’ve helped thousands of businesses worldwide navigate confusing pharmaceutical regulations, and we’re here to give you the industry-leading expertise and assurance you need during this time.

Contact us using the form below to request our remediation services or receive more information.

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