Cleaning validation cited at Toll Compaction plant.

Toll Compaction Services, Neptune, NJ, was slapped in a two-page warning letter dated Jan. 5 for lacking complete cleaning validation studies for compacting equipment in connection with API manufacturing. FDA also wrote up the firm for several supervisory lapses.

The New Jersey district said the company's compactor had been used to process an industrial product containing Teflon prior to a September campaign for production of an unnamed substance. The letter also noted that personnel were not maintaining use logs for processing equipment and for changes the firm made to "critical control parameters" of the manufacturing process without justification or appropriate change controls.

Toll Compaction took in four observations regarding the company's operation including a non-existent quality control unit, lack of procedures designed "specifically for pharmaceutical products," and management approval of cleaning and production records that included changes to unspecified steps without prior approval.

FDA also noted that management personnel admitted having "almost no experience" in the pharmaceutical industry or with GMPs. The letter observed that several current observations were documented in a November 1998 inspection and acknowledged without comment on the firm's Nov. 21 letter requesting a 90-day extension to respond to the 483. At press time, the firm had not responded to calls for comment. Doc. 9857W