1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Brookfield Medical / Surgical Supply, Inc. — FDA 483 Findings
Inspectors Maya M DavisThe 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
The labels and containers ofyour outsomcing facility's drug products do not include information required by section 503B(a)(lO)(A) and (B).
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written and followed .
4Deviation, 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 already distributed.
5Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
7Documentation and records
Master production and control records lack complete manufacturing and control instructions .
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.
