1Other quality system
Cleaning Logs and Cleaning documented in Manufacturing Instructions (i.e.
Inspection Record
Scientific Protein Laboratories — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
No written procedure describing rejection ofglands.
3Validation and qualification
SecondarystaDdards for Amylase and,Protea,se were qualified against the USP reference standardin May 2006.
4Process validation
Process Validation ofPancreatinlPancrealipase API, Pancreatic Enzyme Concentrate (PEC) 120,8 and 1206 are deficient as , : follows: ' , .
5Deviation, CAPA, and investigation
PEC High Lipase lots averaged into compliance with no investigation: , a.
6Other quality system
There is no procedure that describes system suitability requirement.s for the Gas Chro,matography (GC)system.
7Other quality system
Lack oftraceability ofapproximately.lbs ofpancreas'glaqds found in Freezer.on 04/28/09 that was not labeled and was stored on top ofboxes ofpancreas glands, receiving #090300185, unwrapped 'and exposed to the environment.
8Training and personnel
An operator was observed on 04/29/09 to have an earring in his left ear uncovered by his hair net during the unloading of .
9Equipment and facility
There is no name and address ofthe outside storage cold facility listed in the DMF.
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.
