1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
US Specialty Formulations LLC — FDA 483 Findings
Inspectors Lori M Newman · Edmund F Mrark · John R TuohigThe 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
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the sterilization process.
3Laboratory and QC controls
The written stability program for drug products does not include meaningful and specific test methods.
4Regulatory reporting and change control
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under section 510 as required by section 503B(a)(2)(C).
5Equipment and facility
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
6Laboratory and QC controls
Detenrminations of conformance to appropriate written specifications for acceptance are deficient in that they are not made for each lot within each shipment of components used in the manufacture, processing, packing or holding of drug products.
7Contamination control
Protective apparel is not worn as necessaiy to protect drug products from contamination.
8Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
9Laboratory and QC controls
Established laboratory control mechanisms are not followed.
10Equipment and facility
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
12Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
13Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
14Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
15Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency paiiiculate air filters under positive pressure.
About this record
Extracted automatically from the document US FDA published on 2022-09-26. 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.
