1Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed wearing non-sterile gloves.
Inspection Record
The Medicine Shoppe Pharmacy — FDA 483 Findings
Inspectors Jessica L Pressley · Kayla V SpragueThe 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
T he <R edacted B4> intended to render final product sterile was not adequate to accomplish sterilization and was <Redacted B4> Specifically, on 3/10/20, your firm produced ophthalmic Cyclosporin/Coconut Oil 2% eye drops for veterinary use (firm used <Redacted B4> lot <Redacted B4> (Rx <Redacted B4> without utlizing a sterile <Redacted B4>.
3Equipment and facility
Your facility was designed and/or operated in a way that permits poor flow of personnel and materials.
4Aseptic processing and sterility assurance
The ISO 5 classified aseptic processing areas had difficult to clean, particle generating and visibly dirty equipment or surface.
5Aseptic processing and sterility assurance
Personnel engaged in aseptic processing were observed with exposed wrists, exposed hair and exposed mouth.
6Aseptic processing and sterility assurance
Personnel performed aseptic processing outside of an ISO 5 classified aseptic processing area.
7Aseptic processing and sterility assurance
You did not have a HEPA filter over the area to which sterile product was exposed.
8Aseptic processing and sterility assurance
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing areas were not sterile.
9Aseptic processing and sterility assurance
Sporicidal agents were not used in your facility's cleanrooms and/or ISO 5 classified aseptic processing area.
10Training and personnel
Personnel manually contacted the inner surface of the container or closure.
11Aseptic processing and sterility assurance
Sinks or drains were present in the cleanroom where the ISO 5 classified aseptic processing area was located.
12Equipment and facility
Vermin was observed in your production area.
13Environmental monitoring
Unsealed, loose ceiling tiles were observed in your cleanroom.
About this record
Extracted automatically from the document US FDA published on 2020-05-04. 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.
