1Equipment and facility
Routine calibration of automatic, mechanical, and electronic equipment is not performed according to a written program designed to assure proper performance.
Inspection Record
American Specialty Pharmacy — FDA 483 Findings
Inspectors Santos E. Camara · Vilmary Negron RodriguezThe 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 are not followed.
3Process validation
The in-process control procedures were deficient in that they did not include an examination of the clarity of solutions.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
5Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
7Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
8Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
9Contamination 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.
10Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
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.
