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

Source: https://www.keypedia.com/records/483/aqualex-co-ltd/b8e23d12-43d5-40a8-b55d-668613985bca

> FDA 483 for Aqualex Co., Ltd. on October 20, 2023. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aqualex Co., Ltd.
- Inspection Date: 2023-10-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: 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

## Related Documents

- [483 - 2023-10-20](https://www.keypedia.com/records/483/aqualex-co-ltd/582c7fb3-7603-446c-bb9a-ebdbea62ba22)
- [WARNING_LETTER - 2023-10-20](https://www.keypedia.com/records/warning_letter/aqualex-co-ltd/d8ba605a-2f7b-49d4-9fa4-ffcf972fc776)

## Related Officers

- [Wayne D. Mcgrath](https://www.keypedia.com/people/wayne-d-mcgrath/42db5ab0-2e0b-4909-951c-e7621cd04f6e)

Company: https://www.keypedia.com/companies/aqualex-co-ltd/ae48d146-5d62-4a7e-a2ae-12d30e56ac7e

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c