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
Guardian Pharmacy Services — FDA 483 Findings
Inspectors Patty P Kaewussdangkul · Lori G Cantin · Bonita S ChesterThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
3Aseptic 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.
4Other quality system
Air is recirculated to production areas, without adequate measures to control recirculation ofdust.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Material and supplier control
There is a failure to thoroughly review the failure o fa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
8Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
9Equipment and facility
Written procedures are not followed for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
10Equipment and facility
Records are not kept for the cleaning and sanitizing of equipment.
11Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
12Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its cleaning and maintenance.
13Aseptic 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.
14Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
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.
