1Contamination control
Protective apparel is not worn as necessary to protect drug products from contaminat ion.
Inspection Record
Advanced Physician Solutions, Inc. — FDA 483 Findings
Inspectors Binh T. Nguyen · Sangeeta M. Khurana · Liming ZhangThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups arc defic ient.
3Equipment and facility
Records of the calibration checks and inspect ions of autom atic, mechan ical or electronic equipment, includ ing con1puters or related systems are not maintained.
4Laboratory and QC controls
Laboratory controls do not include the esta blishment of scientifically sound and appropriat e test procedures designed to assure that drug products confonn to appropriate standards of identity, strength, quali ty and purity.
5Contamination 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.
6Aseptic processing and sterility assurance
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such req uirements.
7Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the t ime of use.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not estab lishcd and foll owed .
9Aseptic processing and sterility assurance
Asept ic processiug areas are deficient regarding the system for clcnning And disinfecting the to produce aseptic conditions.
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.
