Unique Pharmaceutical, Ltd — FDA 483 Findings

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.

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

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

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

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

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.

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

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

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

Production errors are not fully investigated.