1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Intas Pharmaceuticals Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Routine checking of automatic, mechanical and electronic equipment is not perfo1m ed according to a written program designed to assure proper perfo1mance.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
5Equipment and facility
Equipment and utensils ai·e not maintained at appropriate intervals to prevent containination that would alter the safety, identity, strength, quality or purity of the diug product.
6Other quality system
Laborato1y records do not include complete data derived from all tests, examinations and assay necessa1y to assure compliance with established specifications and standards.
7Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility oftest methods have not been established and documented.
8Equipment and facility
Procedures for the cleaning and maintenance ofequipment are deficient regarding the removal or obliteration of the previous batch identification.
9Documentation and records
Batch production and control records do not include complete info1mation relating to the production and control of each batch.
10Contamination control
Procedures designed to prevent objectionable microorganisms in diug products not required to be sterile are not.
11Quality unit oversight
The procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number ofapproved and rejected batches.
12Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drng products is not of appropriate design to facilitate operations for its intended use.
13Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
14Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diu g products pmpo1iing to be sterile did not include adequate validation ofthe aseptic and sterilization process.
15Process validation
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess.
16Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
About this record
Extracted automatically from the document US FDA published on 2023-07-05. 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.
