1Deviation, CAPA, and investigation
Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Inspection Record
SSM Health Care St Louis — FDA 483 Findings
Inspectors Lisa L. Flores · Robert J. HamThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
The operations relating to the processing of penicillin are not peiformed in facilities separate from those used for other drug products for human use.
3Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
4Process validation
Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
5Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
6Training and personnel
Employees engaged in the manufacture and processing of a dmg product lack the training required to perfo1m their assigned functions.
7Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2024-09-16. 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.
