1Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
Inspection Record
Lowlite Investments, Inc. (dba Olympia Pharmacy) — FDA 483 Findings
Inspectors Caryn M. McnabThe 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
Aseptic processing areas are deficient regarding the sys~m for moD.itoring environmental conditions.
3Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate sampling plans designed to assure that in-process materials and drug products conform to appropriate staridards of identity, strength, quality and purity.
4Training and personnel
Clothing ofpersonnel engaged in the processing ofdmg products is not appropriate for the duties they perform.
5Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
6Other quality system
Time limits are not established when.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under po sitive pressure.
8Contamination control
Procedures designed to prevent microbio.logical contamination.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are [lot established, \vritten, and followed.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
11Aseptic processing and sterility assurance
Each batch of drug product purporting to be ste.rile and pyrogen-free is not laboratory tested to detemiine conformance to such requirements.
12Contamination control
Separate or defined areas to prevent contamination.
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.
