1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Inspection Record
Caraco Pharmaceutical Laboratories — FDA 483 Findings
Inspectors Patsy J Domingo · Jonathan R. Loving · Adam J. WilsonThe 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
Written records of major equipment cleaning, maintenance, and use are not included in individual equipment logs.
3Equipment and facility
The persons performing and double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
4Equipment and facility
Inspection of the packaging facilities immediately before use is not done to assure that all drug products have been removed from previous operations.
5Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
