SmithKline nets a single observation for improper testing of incoming shipments.(HUMAN DRUGS)

SmithKline Beecham, Bristol, TN Nashville District

An inspection of SmithKline Beecham's Bristol, TN, site, dedicated to the manufacturing of non-sterile penicillin products for human and veterinary use, found just one deficiency, FDA investigator George Flynn noted on the 483 issued.

The firm, which manufactures tablets, capsules and powders for oral suspensions, was "erroneously performing identity testing on composite samples, instead of individual container samples, collected from incoming shipments of excipients & active pharmaceutical ingredients," Flynn wrote.

The company's practice was to composite the samples collected from more than one container and to test only the composite. "For example, I.D. testing done on incoming lots of Mannitol USP, and additional excipients," Flynn wrote in the 483 issued following the inspection conducted Feb. 13-17, 2006.

According to management, incoming shipments of components were sampled upon receipt from an outside vendor in accordance with SmithKline Beecham's written procedure. Amoxicillin APIs were manufactured at a GlaxoSmithKline plant located in Singapore. The sample collected for identification testing was not a composite sample and was collected from one container per incoming batch. Because these APIs were manufactured by GlaxoSmithKline, Flynn noted, "I did not object to their practice of performing identity testing on a sample collected from one container per batch received."

The blends of clavulanate potassium were manufactured at a Glaxo plant located in the United Kingdom. On each incoming batch, the firm collected a composite sample and did an identity test on the composite sample.

"It should be noted that this deficiency will be applicable to all GSK-regulated manufacturing sites that are regulated by FDA," Flynn wrote.

Management promised to correct this deficiency.

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