1Documentation and records
Batch production and control records are not prepared for each batch ofdrug product produced and do not include compiete | information relating to the production and control ofeach batch.
Inspection Record
Eastern Pharmacy, Inc. — FDA 483 Findings
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 drug products purporting to be sterile are not established, written, and followed, .
3Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing ofdrug products.
4Aseptic processing and sterility assurance
Each batch ofdrug product purporting to-be sterile is not laboratory tested to determine conformance to such requirements.
5Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
6Training and personnel
Employees engaged in the processing and packing ofa drug product lack the education, training, and experience required to perform their assigned functions.
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.
