Bioport Corporation — FDA 483 Findings

The LUMAC is notperiodically reviewed for accuracy and completeness by thequality unit.

The firm has not set specifications forbioburden testing though they began testing for pre-filtration bulk on 2/20/97, Organisms found include but are not limited to Bacillus species, Corynebacterium species, Pseudomonas species,Micrococcus species, and Acinetobacter species.

Asmoke test was performed (and videotaped) in April 1999; however, there are no records to indicate the reason, or to provide an evaluation of its acceptability and Quality Assurance : approval.

The investigation report, approved by management 10/11/00, indicated thatafl?

The firm has not conducted an investigation as a result ofthis VAERS report, B.

There was no preventive maintenance program, including filter inspection and replacement .

Smoke testing was not performed in conjunction with allowable low and high air velocity range, for the HEPA filter bank.

There is no mirrorin gowning room 48 to assure that employees comply with gowning procedures, .

Pursuant te Section 704(b) of the Federal Food, Drug and Cosmetic a Act, or : ; .

Batch production records indicate that Witter Vials were removed during filling: ad.

There is no assurance that environmental samples taken in the filling suite in Building@& Room @@@ and the capping area Building @} RoomQB are representative ofactual .

Empty chamber cold spot heat distribution studies in 1996 indicate that protocol - | .

"Planned Deviations” allow departures.from procedures or manufacturing processes and no reports are i | |.

Loaded chamber cold spot determinations have not been performed for minimum and so "maximum loads, for each vial size.

Somework orders for corréctive maintenance or repairs were marked as“Critical Systems Work Order,” SEE however, were not signed/dated as reviewed by Quality Assurance, Quality Control, Critical Systems Se Committee, or other management as required, In addition, there was no indication that product impact was ot evaluated.