What is Remediation FDA

1. What is Remediation FDA? Let us take case of one medical device Industry with quality system established with ISO 13485, EU MDR and US FDA relevant requirement. Products are registered with CE mark for Export to Europe. The firm is US FDA approved and doing business in USA with substantial financial stake. Being US FDA firm, it must undergo US FDA inspection at regular interval. This is decided by US FDA as when to inspect and what scope they will cover. The firm undergoes one such inspection and Inspector finds some compliance issue points during inspection. These issues need to be resolved to US FDA satisfaction failing to do that satisfactorily generates FDA 483, Warning letter. FDA remediation thus is nothing but to address the compliance issue raised. Very important aspect of resolving these issues is to first understand all problems, make effective CAPA plan, (it is assumed that CAPA plan already takes care of issue that such problems will not repeat in future), Execute them. Though it is said very simply, making CAPA plan needs correct identification of root cause. This process often does not get completed. People often make mistakes in identifying cause and root cause and often considers cause as root cause. This leads to imperfect preventive action, and it often leads to repeat of this issue again in future. This is failure of CAPA.

2. Couple of time improper Risk assessment also results into failure and root cause can be wrong or imperfect risk assessment. In all such cases the firm needs an expert to check all documentation from plan to execution and its efficacy. Right reasoning to designate root cause. All thee requires real experts with lot of practical experience. It often happens that firm’s expert fails to understand or identify problem. Attempting to uncover systemic issues and creating plan to correct them is considerable challenge even for big firms. In such cases it is, therefore, highly recommended that firm should take help of FDA Remediation consultants. Many a time these consultants are ex US FDA inspectors or have very rich experience in compliance issue redressal. Imagine the failure of CAPA, issuance of 483 and Warning letters. Failure to address them successfully could result into, Import ban, recall, detention and in worst cases product seizure. These are all open actions and publicized. This can disturb firm’s global supply chain, financial damage and reputation damage. If anyone receives 483, warning letter or any other enforcement action, it is highly recommended to have FDA Remediation consultants on hire to resolve these issues rather than attempting self.