1Equipment and facility
Failure to ensure that new and modified facilities and equipment are qualified.
Inspection Record
Apitoria Pharma Private Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Failure to establish adequate manufacturing instructions in the production records for diug substances and inte1mediates.
3Equipment and facility
Equipment used in the manufacturing of diug substances and inte1mediates is not of adequate upkeep to facilitate operations for its cleaning and maintenance.
4Equipment and facility
Your equipment are not adequately qualified.
5Other quality system
(bH"'I (brc"'l The water system design and the water sampling method to assure quality of •1 water are l not adequate.
6Quality unit oversight
Failure of your quality unit to establish a system to release or reject raw materials, inte1mediates, packaging and labeling materials.
7Validation and qualification
Failure to ensure ti·aining is regularly conducted by qualified individuals and covers, at a minimum, the paiiicular operations that each employee perfo1m s and CGMP as they relate to the employee's functions.
8Cleaning validation
Your equipment cleaning validation protocol is inadequate.
9Quality unit oversight
Failure ofyour quality unit to review and approve all appropriate quality-related documents.
About this record
Extracted automatically from the document US FDA published on 2024-10-07. 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.
