1Other quality system
There are no written procedures for production and process conh'ols designed to assure that the diu g products have the identity, strength, quality, and purity they pmport or are represented to possess.
Inspection Record
Cipla Limited — FDA 483 Findings
Inspectors Rajiv R SrivastavaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a dmg product do not have the suitable size and constmction to facilitate cleaning, maintenance, and proper operations.
3Other quality system
addresses NVPC concerns in the ~b>< 4 > I Area (Room tbJ <4> .
4Equipment and facility
Equipment for adequate control over air pressure, micro-organisms and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drng product.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products pmpo1iing to be sterile did not include adequate validation of the aseptic and sterilization process.
6Aseptic processing and sterility assurance
adch·esses smoke study concerns related to air flow pattern evaluations.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been akeady distributed.
8Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.
9Equipment and facility
Equipment used in the manufacture, processing, packing or holding of di11g products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
10Aseptic processing and sterility assurance
Procedmes designed to prevent Inicrobiological contamination of diug products pmpo1i ing to be sterile are not established, written and followed.
11Quality unit oversight
Written procedures are not reviewed and approved by the quality control unit.
12Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a diug product.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
14Material and supplier control
The specifications for in-process materials are deficient in that they do not include a description of the sampling plan for in-process materials.
15Aseptic processing and sterility assurance
addresses smoke study concerns related to air flow pattern evaluations.
About this record
Extracted automatically from the document US FDA published on 2019-10-11. 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.
