1Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination ofthe drug product.
Inspection Record
Unique Pharmaceutical, Ltd — FDA 483 Findings
Inspectors Scott T BallardThe 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 proces.-;ing ofdrug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to detennine confonnance to such requirements.
4Other quality system
Production errors are not fully investigated.
5Laboratory and QC controls
Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory confonnance to the final specifications and identity and strength ofeach active ingredient prior to release.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
10Labeling and packaging
The labels of your firm's drug products do not always contain information required by section 503(b)(a)(J 0).
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.
