Inspection Record

Unique Pharmaceutical, Ltd — FDA 483 Findings

US FDAInspected 2015-07-10Published 2024-01-17 10 findingsLaboratory and QC controlsAseptic processing and sterility assuranceTraining and personnelLabeling and packagingContamination controlOther quality system

Inspectors Scott T Ballard · Darla J. ChristopherThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.

2Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

3Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for moni toring environmental conditions.

4Training and personnel

Clothing of personnel engaged in the processing ofdrug products is not appropriate for the duties they perform.

5Labeling and packaging

Tlie labels efyeHr firm's elrug J3re8Hets ae HOt ahYays eoRtaiR iRfermatioa reEJ:airea b~· seetien 503(b)(a)(l0).

6Contamination 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.

7Contamination control

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

8Aseptic 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.

9Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.

10Other quality system

Production errors are not fully investigated.

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.

Other records for this company

2016-07-25 · US FDA · 5 findings2015-07-10 · US FDA · 10 findings
Unique Pharmaceutical, Ltd findings history — including this company's other documents US FDA documents, 2024 Go to Findings search