1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Pharmakon Pharmaceuticals Inc. — FDA 483 Findings
Inspectors Emily J Orban · Emilie Kahn · Gary C Pecic and 1 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions.
4Aseptic 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.
5Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
6Other quality system
Testing and release of dmg product for distribution do not include appropriate laborat01y determination of satisfact01y confonnance to the final specifications and identity and strength of each active ingredient prior to release.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
8Equipment and facility
Your outsourcing facility has not submitted a complete rep01i to FDA identifying all products compounded at your facility during the previous six months as required by section 503B(b)(2)(A).
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency par ticulate air filters under positive pressure.
10Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
11Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and 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.
12Labeling and packaging
The labeling of your outsourcing facility's drug products does not include information required by sections 503B(a)(10)(A) and (B).
13Equipment and facility
The operations relating to the processing of penicillin are not performed in facilities separate from those used for other drug products for human use.
14Aseptic 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.
