1Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
Inspection Record
Guardian Pharmacy Services — FDA 483 Findings
Inspectors Patrice S Hall · Anh LacThe 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 do not include validation ofthe sterilization process.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
4Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
5Equipment 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.
6Other quality system
DEPARTMENTOFHEALIBANDHUMANSERVICES FOOD AND DRUG ADJ\11NISTRATION DATE{S) OF INSPECTJON DISTRICT ADDRESS ANO PHONE NUMBER 9/12/2016-10/21/2016* 4040 North Central Expressway, Suite 300 FEINUMBER Dallas, TX 75204 3012669715 (214)253-5200 Fax: (214)253-5314 NAME AND TITLE OF INDMDUAL TO Vll'HOM REPORT ISSUED Jack R.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
8Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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.
