1Other quality system
The following discrepancies were noted during the microbial testing ofthewater used in the testing and cleaning of APIs manufactured for the U.S.
Inspection Record
Cosma SpA — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Failure to maintain complete data derived from all testing and to ensure compliance with established API
3Material and supplier control
API product labels intended to be transferred outside the control of the manufacture’s material management system do not contain the retest date or the name and address of the manufacturer.
4Cleaning validation
The following cleaning discrepancies were noted during the review of equipment used in the manufacturing of APIs: oe spot checking is performed in support of cleaning validations.
5Training and personnel
Training files do not contain details to ensure personnel are trained on the particular operations performed.
6Other quality system
The following discrepancies were noted during the review of production activities: EMPLG EIS)
7Equipment and facility
The following discrepancies were noted during the review of the maintenance and calibration program: 1.
8Other quality system
Failure to maintain complete data derived from all testing and to ensure compliance with established specifications and standards pertaining to data retention and management, Specifically, © 1.
9Documentation and records
Working copies of cleaning batch records are pot exact copies of the master records.
10Other quality system
Quality was not performing the following activities: 1.
11Stability and storage
During the review of stability monitoring of APIs the following discrepancies were noted: 1.
About this record
Extracted automatically from the document US FDA published on 2017-05-11. 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.
