1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological containination of diug products purpo1ting to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Cadila Healthcare Ltd. — FDA 483 Findings
Inspectors Justin A BoydThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
In-process specifications are not detennined by the application of suitable statistical procedures where appropriate.
3Equipment and facility
The production ai·ea air supply lacks an appropriate air filtrntion system.
4Computer system validation
Failure to maintain a backup file of data entered into the computer or related system.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been aheady distributed.
9Aseptic processing and sterility assurance
Aseptic processing areas ru·e deficient regarding air supply that is filtered through high-efficiency pruticulate air filters under positive pressure.
10Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the diug product.
11Laboratory and QC controls
Laborato1y contrnls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that diu g products confo1m to appropriate standai·ds of identity, strength, quality and purity.
12Process validation
There are no written procedures for production and process controls designed to assure that the diug products have the identity, strength, quality, and purity they purpo1t or are represented to possess.
13Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1ting to be sterile are not established and followed.
14Documentation and records
Master production and control records lack complete manufacturing and control instrnctions.
About this record
Extracted automatically from the document US FDA published on 2019-05-14. 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.
