FDA-483 Objectionable Observations and FDA Warning Letters

GCGI knows what the FDA expects, and how to effectively respond to FDA-483s and FDA Warning Letters.

Our response addresses systemic issues preventing higher-level sanctions.

For an effective solution of regulatory deficiencies noted, GCGI develops a Quality Improvement and Implementation Plan (QIIP) taking into consideration the impact to product quality & GMP operations. The plan not only describes how to correct and prevent each objectionable observation cited, but also includes how the underlying root cause and systemic issues will be addressed. The plan includes the following activities:

  • Ensuring that immediate corrective actions are implemented.
  • Remediating urgent quality issues.
  • Assisting companies in the development of a Management Action Plan rectifying all cGMP deficiencies.
  • Ensuring that all CAPAs addressees systemic issues effectively.
  • Prioritizing and monitoring long-term corrective actions.
  • Ensuring that companies get more effective in meeting GMP regulations under the authority of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
  • Assisting companies with updates and commitments to the Agency.
  • Ensuring knowledge transfer by training personnel in technical and regulatory GMP operations.
  • Conducting a thorough mock follow-up audit ensuring the accuracy, integrity and completeness of the Quality Improvement and Implementation Plan.

FDA 483 &

​Warning Letters

Johnny Guerra assists companies responding to FDA-483 Objectionable Observations and FDA Warning Letters (WL).

Guerra’s vast experience addresses systemic issues of what actually needs to be implemented to be FDA-regulatory compliant. 

An in-depth evaluation of each FDA-483 observation is executed followed by technical and FDA-regulatory discussion of all cGMP deficiencies. The emphasis is placed on systemic root causes and Corrective and Preventive Action Plans (CAPAs). 

​“Established since 1999”

“GCGI’s level of experience, credibility and unique expertise with FDA expectations really helped our manufacturing and laboratory operations put in place a direct compliant structure for good SOPs and recordkeeping, followed by a sustainable system still in place today. Johnny Guerra trained all our personnel, fixed-up all of our GMP systems resulting in zero FDA-483 observations from the Agency during a follow-up inspection”.

​GCGI was hired by a pharmaceutical company to address FDA Warning Letter issues involving four different sites. The Warning Letter raised concerns on the Corporate Quality System to achieve overall compliance with cGMPs.

“Guerra’s expertise and implementation of a QA Compliance Investigation Unit allowed us to resolve numerous quality issues that were impacting the quality of our drug products. His unique teaching style allowed us to understand and properly document all laboratory failure investigations and manufacturing quality events. We were able to combine good regulatory writing techniques, practical understanding of process development to process validation and analytical method validations as well. We learned how to convert technical and regulatory concepts into practical and effective CAPAs. We advise other companies not to wait for a Warning Letter; just hire Johnny Guerra to prevent business interruptions and impact to company’s product branding!”  

Learn How To Think Like The FDA ®