1Equipment and facility
Your facility design allowed the influx ofpoor quality air into a higher classified area.
Inspection Record
Lifetime Value Pharmacy III Inc. — FDA 483 Findings
Inspectors Christopher R CzajkaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
Personnel did not disinfect and change gloves frequently enough to prevent contamination.
3Aseptic processing and sterility assurance
Non-sterilized and Non-depyrogenated equipment was used in sterile drug production.
4Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in an area adjacent to the ISO 5 classified aseptic processing area during aseptic production.
5Contamination control
Non-microbial contamination was observed in your production area.
6Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
7Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle-generating and visibly dirty equipment or surface.
8Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
9Training and personnel
l/10/2019-2/21/2019* 301 E 17th St TYPE ESTABLISHMENT INSPECTED Compounding Pharmacy Personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
