1Stability and storage
Your firm failed to (adequately) validate the analytical method for stability studies ofAPI, to support the intended commercialization period and expiry.
Inspection Record
Galaxy Surfactants Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm failed to use water that is suitable for manufacturing ofAPI, ahi Specifically, ; ; You manufacture water water) at your site from municipality water.
3Training and personnel
Your firm failed to provide GMP training to your employees at the particular operations that the employee performs and GMP as it relates to the employee's functions.
4Cleaning validation
Your firm failed to establish anappropriate equipment cleaning procedure to assure an adequate cleaning of equipment and its subsequent release for use in the manufacture ofintermediates and APIs.
5Equipment and facility
Your firm failed to conduct appropriate qualification (DQ, IQ, OQ & PQ) of critical equipment.
6Other quality system
Your APQR procedure is deficient such that: —_ a.
7Documentation and records
You do not ensure product quality uniformity from batch to batch such that your Batch Manufacturing Records (BMR) does not conform to the Master Formula Record (MFR).
8Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
9Stability and storage
You failed to place on stability at least one batch per year ofmanufactured APIs and to test at least annually to confirm the stability characteristics ofthe APIs, appropriate storage conditions and confirm the expiry dates.
About this record
Extracted automatically from the document US FDA published on 2018-06-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
