Hybrid Pharma LLC – FDA 483, Nov 9, 2023

This FDA Form 483 document outlines multiple deficiencies observed during an inspection of an outsourcing facility. The facility's aseptic processing areas were found to be deficient in several aspects: the system for cleaning and disinfecting equipment to achieve aseptic conditions, the validation of the aseptic process to prevent microbiological contamination, and the air supply, which lacked high-efficiency particulate air filters under positive pressure. Furthermore, the floors, walls, and ceilings in these areas were not smooth or hard surfaces, hindering easy cleaning.

Equipment used in manufacturing was not appropriately designed for easy cleaning and maintenance. The facility was compounding drug products using bulk drug substances not on the drug shortage list or FDA's clinical need list, violating Section 503B of the FD&C Act.

Laboratory control deficiencies included the absence of scientifically sound specifications, standards, sampling plans, and test procedures for components, containers, in-process materials, and drug products. The accuracy, sensitivity, specificity, and reproducibility of test methods were not established or documented. Drug product release for distribution did not include appropriate laboratory determination of conformance to final specifications and identity/strength of active ingredients.

Additionally, the outsourcing facility failed to submit a required six-month product compounding report to FDA per Section 503B(b)(2)(A) of the FD&C Act. Master production and control records lacked complete manufacturing and control instructions, sampling/testing procedures, specifications, and special notations/precautions.