1Laboratory and QC controls
The establishment of test procedures including any changes thereto, are not drafted by the appropriate organizational unit.
Inspection Record
Portage Pharmacy, Inc. — FDA 483 Findings
Inspectors Rebecca E. Dombrowski · Russell K. RileyThe 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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
4Equipment and facility
The operations relating to the processing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.
5Quality unit oversight
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.
6Stability and storage
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.
7Stability and storage
Results of stability testing are not used in determining expiration dates.
8Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
9Other quality system
Records associated with drug produd: produetion and control and within the retention period for SU¢b records, were not made readily available for authorized inspection.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
12Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
13Laboratory and QC controls
Established test procedures are not followed.
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.
