1Environmental monitoring
The lSO 5 positive pressure clean room is not operated appropriately to ensure adequate air flow within the room .
Inspection Record
Tri-Coast Pharmacy Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Environmental monitoring
The HEPA filters located in the lam in ar air no <Redacted B4> Hood <Redacted B4> and Hood <Redacted B4> within the ISO 5 pos itive clean room contain significant brown stains.
3Material and supplier control
One (1) vial <Redacted B4> vials of Calm Me Injection from Lot #08032016C, BUD: 01/30/2017 was found to contain an unknown foreign material.
4Aseptic processing and sterility assurance
Wipes used in the ISO 5 hoods (negative and pos itive pressure clean rooms) are not sterile.
5Aseptic processing and sterility assurance
Personnel donned gowning apparel improperly, in a way that may have caused the gowning Specificslly, a) On 10/13/16, your firm's operators were observed donning their sterile hood, sterile mask and <Redacted B4> I
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.
