1Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure the active pharmaceutical ingredient (API) and intermediates manufactured at your facility are in compliance with CGMP.
Inspection Record
Almon Healthcare Private Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
3Other quality system
Failure to monitor thebe system to ensure that water is of appropriate quality.
4Material and supplier control
Failure to ensure that all specifications are scientifically sound and appropriate to ensure that your raw materials and API conform to established standards of quality and purity.
5Cleaning validation
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates and API.
6Computer system validation
Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.
7Stability and storage
Failure to store stability samples in containers that simulate the market container.
8Equipment and facility
Failure to properly maintain buildings and facilities used in the manufacture of intermediates and API.
9Laboratory and QC controls
Failure to retain sufficient quantities of reserve sample to conduct analyses.
10Equipment and facility
Pailure to adequately validate written procedures for the cleaning and maintenance of equipment.
11Laboratory and QC controls
Your firm failed to use validated and stability-indicating test procedures.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
