# FDA 483 - Galaxy Surfactants Limited - March 30, 2018

Source: https://www.globalkeysolutions.net/records/483/galaxy-surfactants-limited/951ee4c0-bc46-4319-82e8-1b7e5add20c6

> FDA 483 for Galaxy Surfactants Limited on March 30, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Galaxy Surfactants Limited
- Inspection Date: 2018-03-30
- Product Type: Drugs
- Office Name: Division of Pharmaceutical Quality Operations II
- Summary: This FDA Form 483 details observations from an inspection, highlighting deficiencies in the facility's quality control unit, analytical methods, stability studies, employee training, and equipment cleaning procedures.

**Quality Control Unit Deficiencies:**
*   SOP # QC029-01 for water sampling and testing lacks specifications for REDACTED water used in API manufacturing.
*   SOP # QC003-00 for finished goods release was not followed; a non-USP, non-validated method (OCN_USP) was used to release multiple batches of REDACTED (e.g., Lot # REDACTED) between 2/17/2018 and 3/5/2018.
*   The process validation report (PVR/OCN-Retro/00) omitted critical parameters, including manufacturing instructions for Stages REDACTED and the REDACTED blending stage, equipment identity for Stages REDACTED and blending, in-process specifications, and 53 out of REDACTED assay data points from Table 18.3.

**Analytical Method Validation Issues:**
*   The GC method GQM 157, used for stability studies of API, REDACTED, is neither a USP nor an internally validated method.
*   Forced degradation studies using GQM 157 are incomplete.
*   A non-validated HPLC method was used for forced

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/rajiv-r-srivastava/05b42bfd-0cf4-42ce-89e1-b81bf36eaa17)

Company: https://www.globalkeysolutions.net/companies/galaxy-surfactants-limited/85574102-8244-4004-a4f3-701e41489a14

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-ii/930d696b-0ac7-4de4-8268-e3db00525bc6