1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
Inspection Record
Americare Compounding, LLC. — FDA 483 Findings
Inspectors James A. LiubicichThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Specifically, the firm does not have written procedures for any of the operations conducted at the firm including sterile drug p rocessing, testing procedures, stability program, quality assurance, etc.
4Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
5Equipment and facility
The operations relating to the processing and packing of penicillin are not performed in facilities separate from those used for other drug products for human use.
6Labeling and packaging
Reserve drug product samples are not retained and stored under conditions cons istent with product labe ling.
7Other quality system
Air-handling systems for the processing and packing of penicillin are not completely separate from those for other drug products for human use.
8Stability and storage
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug purporting to be sterile are not established and writt en .
10Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
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.
