1Aseptic processing and sterility assurance
Aseptic processing areas deficient regarding the system for cleaning and disinfecting the room and equipment to produce asept ic 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
2Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products .
3Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
4Contamination control
The control system necessary to prevent contamination or mix-ups are deficient.
5Training and personnel
Employees engaged in the processing of a drug product lack the training required to perform their assigned functions.
6Equipment 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.
7Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
8Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization proces.
10Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to detem1ine conformance to such requirements.
11Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
14Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
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.
