1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and d isinfecting the room and equjpment to produce aseptic conditions.
Inspection Record
Dougherty's Pharmacy — FDA 483 Findings
Inspectors Shelby N. MarlerThe 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 ofdrug products purporting to be sterile are not established, written, and followed.
3Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
4Laboratory and QC controls
Laboratory controls do not include the establishment ofscientifically sound and appropriate test procedures designed to assure that drug product containers conform to appropriate standards of identity, strength, quality and purity.
5Stability 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 time ofuse.
6Training and personnel
Clothing of personnel engaged in the manu facturing and holding ofdrug products is not appropriate for the duties they perform.
7Complaint and recall handling
The distribution system is deficient in that eac b lot of drug product cannot be readily determined to facilitate its recall if necessary.
8Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is no t ofappropriate design to faci litate operations for its intended use .
9Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and stre ngth of each active ingredient prior to release.
10Complaint and recall handling
Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.
11Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental 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.
