Labocont Industrial SRL FDA Warning (2018)

Detailed Analysis

False Claims and Regulatory Violations

Provide a comprehensive investigation into the inadequacies in data records and reporting for all products manufactured for the U.S. market and within expiry. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies.In addition, describe all parts of your facility’s operations in which CGMP information is not recorded and maintained. Include a corrective action and preventive action (CAPA) plan to remediate data recording and retention practices throughout your operation.

Potential Health Risks

Summarize all in-date batches of drug products produced at your facility and distributed in the U.S. market, and perform a thorough risk assessment of the impact of conducting(b)(4)and non-(b)(4)manufacturing operations within the same facility.

Outline your proposed market action plan, including customer notifications and recalls, to address all products in the U.S. supply chain at risk for potential(b)(4)contamination.

Provide a risk assessment summarizing the affect of incomplete data on assessing laboratory control and product quality.

Regulatory Context

Provide your plan to completely and comprehensively separate your facility for the manufacture of(b)(4)drugs. Commit to one of the following two options for the facility you have used to manufacture(b)(4).

Provide a detailed corrective action plan that describes how you intend to ensure the reliability and completeness of all the data you generate, including analytical and manufacturing data. This should include procedures that detail your documentation, data evaluation, review, retention, and quality oversight practices. Outline how you will assess your corrective actions for effectiveness.

Provide your plan of action to complete validation (or verification, for compendial methods) for all analytical methods used in association with products that are shipped to the U.S.