1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions .
Inspection Record
Millers of Wyckoff, Inc. — FDA 483 Findings
Inspectors Liatte Krueger · Susan M. Joseph · Zakaria I. GaniyuThe 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 of drug products purporting to be sterile are not established, written, and followed.
3Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactor y conformance to the final specifications prior to release.
4Equipment and facility
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
5Equipment and facility
The flow ofcomponents, drug product containers, in-process materials, and drug products though the building is not designed to prevent contamination.
6Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
7Material and supplier control
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
8Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
9Stability 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 of use.
10Aseptic processing and sterility assurance
Procedures designed to prevent microbiologicaJ contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
11Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment 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.
