1Stability and storage
The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability.
Inspection Record
Indoco Remedies — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding.
5Labeling and packaging
There is no documentation of the examination and review of labels and labeling for conformity with established specifications.
6Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
7Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength.
About this record
Extracted automatically from the document US FDA published on 2018-02-15. 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.
