1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include valjdation ofthe sterilization process.
Inspection Record
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written and followed.
3Aseptic processing and sterility assurance
Aseptic processing areas ar~ deficient regarding the system for monitorrng environmental cond.itions.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
5Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
6Stability and storage
Drug products do not bear an expiration date detennined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
8Material and supplier control
Each lot of a component, drug product containers, and closures liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.
9Other quality system
In addition, DE PARTMENT OF HEALTil AND UUMAN SERVICES FOOD AND DRUO ADMINISTRATION · OATE(S) OF INSPECTION DISTRICT ADORESS AND PI<ONC: tWIJBER 555 ~·linderley Place, Suite 200 12/01/2014 - 12/22/2014 FEINUM6ER Maitland, FL 32751 (407) 475-4700 Fax: (407) 475-4768 3011123993 Industry Information: ~M.fda.gov/oc/industry NAME AND TinE OF INOMOVAL TO WHOM REPORT ISS\Ja> TO: Jeffrey s.
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.
