FDA EIR - PLD Acquisitions LLC - January 30, 2019

An FDA inspection of PLD Acquisitions LLC, also known as Avema Pharma Solutions and P&L Developments LLC, located in Doral, FL, was conducted from January 17-30, 2019. This comprehensive Current Good Manufacturing Practices (cGMP) inspection, guided by 21 CFR regulations, covered drug products such as Ibuprofen, Loratadine, and Aspirin tablets, focusing on quality, facilities, equipment, materials, production, and laboratory controls. The inspection concluded with the issuance of a five-item FDA-483 observation form detailing significant deficiencies. Key violations included inadequate laboratory investigations, particularly concerning out-of-specification stability failures for distributed drug batches, with insufficient root cause analysis, lack of scientific rationale, and failure to conduct necessary risk assessments. The firm also lacked proper written procedures and execution for equipment cleaning and maintenance, evidenced by unmaintained dust filter cartridges, product-contact hoses with visible residue and damage, and deficient cleaning validation studies. Insanitary conditions were identified in both production and quality control laboratory areas, posing contamination risks. Furthermore, the company failed to detect, segregate, and appropriately manage damaged equipment, and did not adequately perform or document risk assessments and approvals for corrective and preventive action (CAPA) time extensions. Management pledged to correct these issues and provide a written response within fifteen business days.