1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
American Pharmacy of Illinois Inc. dba Alwan’s Pharmacy — FDA 483 Findings
Inspectors Christina A. MillerThe inspectors who signed the published document.Inspector lookup
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 ofdrug products purporting to be sterile are not established.
3Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
5Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Training and personnel
Employees engaged in the processing ofa drug product lack the training required to perform their assigned functions.
7Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
9Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
10Equipment and facility
Equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
11Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactor y conformance to the identity and strength of each active ingredient prior to release.
12Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
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.
