1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not written.
Inspection Record
SCA Pharmaceuticals, LLC. — FDA 483 Findings
Inspectors Jonah S Ufferfilge · John P MistlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
3Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
4Quality unit oversight
There is no quality control unit.
5Equipment and facility
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
8Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
9Other quality system
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate phase of manufacturing of the drug product.
10Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2023-12-19. 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.
