1Equipment and facility
Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
Inspection Record
Abrams Royal Pharmacy — FDA 483 Findings
Inspectors Scott T Ballard · Elisa M. FlemingThe 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 system for monitoring environmental conditions.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that conform to appropriate standards of identity, strength, quality and purity.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
6Quality unit oversight
The quality control unit lacks authority to fully investigate errors that have occurred.
7Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
8Documentation and records
Batch production and control records do not include complete information relating to the production and control ofeach batch.
9Contamination control
There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.
10Equipment and facility
Procedures describing the calibration ofinstruments, apparatus, gauges and recording devices are deficiently written or followed.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
12Complaint and recall handling
Procedures describing the handling ofall written and oral complaints regarding a drug product are not foJJowed.
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.
