1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Pyramid Laboratories, Inc. — FDA 483 Findings
Inspectors Jennifer M. Gogley · 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
2Laboratory and QC controls
The accuracy, sensitivity, and specificity oftest methods have not been established.
3Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
4Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate vvritten specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
6Process validation
Time limits are not established when approp1iate for the completion ofeach production phase to assure the quality of the drug product.
7Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
8Quality unit oversight
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
9Quality unit oversight
The quality control unit lacks authority to fully investigate errors that have occurred.
10Equipment and facility
Written records of major equipment use are not included in individual equipment logs.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
12Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
13Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
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.
