1Equipment and facility
Your fnm's cleaning processes for non-dedicated equipment have not been adequately established and validated.
Inspection Record
Orchid Pharma Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
Appropriate conti·ols are not exercised over computer or related system to assme that the changes in the master production or conti-ol records or other records are instituted only by authorized persons.
3Equipment and facility
Appropriate qualification ofcritical equipment and ancillaiy systems are not completed according to established specifications.
4Quality unit oversight
The responsibilities and procedure applicable to the quality control unit are not in writing and/or fully followed.
5Cleaning validation
Cleaning procedures do not contain sufficient details to enable operators to clean each type of equipment in a reproducible and effective manner.
6Other quality system
You have not established the written procedure to ensure that your process can perfo1m effectively and reproducibly to manufacture an inte1mediate or API meeting its predete1mined specifications and quality attributes.
7Material and supplier control
You failed to test samples of each component for confo1mity with all appropriate written specifications for purity, sti-ength, and quality.
About this record
Extracted automatically from the document US FDA published on 2026-04-09. 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.
