1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
The Apothecary Shoppe, LLC — FDA 483 Findings
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.
3Aseptic 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.
4Aseptic processing and sterility assurance
Aseptic processing areas are defic ient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation ofthe sterilization process.
8Equipment and facility
Routine calibration ofelectronic equipment is not performed according to a written program designed to assure proper performance.
9Equipment and facility
Writteu procedures are not established for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.
10Training and personnel
Clothing ofpersonnel engaged in the manufacturing and processing ofdrug products is not appropriate for the duties they perform.
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.
