1Laboratory and QC controls
Established sampling plans and test procedures are not followed.
Inspection Record
Zydus Lifesciences Ltd. — FDA 483 Findings
Inspectors Anastasia M Shields · 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
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile are not followed.
3Training and personnel
Employees engaged in the manufacture ofa di11g product lack the training required to perfo1m their assigned functions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of mug products pmpo1ting to be sterile did not include adequate validation of the aseptic process.
5Process 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.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Equipment and facility
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessa1y to assure proper cleaning and maintenance.
8Equipment 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.
9Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been akeady distributed.
About this record
Extracted automatically from the document US FDA published on 2024-04-29. 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.
