FDA 483 - Aqualex Co., Ltd. - October 20, 2023

This FDA Form 483 details observations from an inspection, highlighting significant deficiencies in the facility's quality control unit, manufacturing processes, and laboratory controls for drug and cosmetic product manufacturing.

**Key Observations:**

* **Observation 1: Quality Control Unit Deficiencies:** The responsibilities and procedures of the quality control unit are not fully documented or followed. * Cleaning procedures (SOP HSOP-H-001) for manufacturing equipment, used for both drug and cosmetic products, have never been validated. * Lack of procedures for good documentation practices and issuance of GMP records. QC and production employees freely print and shred official GMP records (e.g., analytical forms, temperature/pressure monitoring) without QA oversight or reconciliation. * Absence of a procedure for manufacturing equipment qualification, and equipment used for drug product manufacturing is not qualified.

* **Observation 2: Lack of Stability Testing Program:** No written program exists to assess drug product stability. The firm lacks a procedure for stability studies and has never performed studies at 25°C/60% RH to demonstrate product quality retention.

* **Observation 3: Inadequate Laboratory Controls:** Sampling plans and test procedures for components and drug products are not scientifically sound. * No growth promotion testing or positive controls are used for media in total microbial count testing. Media appeared dried out after incubation. * The method for total microbial