Broken bottle, glass contamination the focus of Amersham inspection. (Human drugs).Amersham Mediphysics, Arlington Heights Arlington Heights, village (1990 pop. 75,460), Cook county, NE Ill., a residential suburb of Chicago; founded 1836, inc. 1887. Its manufactures include machinery, drugs and medical equipment, and metal fabrication. Arlington Park racetrack is there. , IL, received a 10-item 483 from FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. following a June 2001 investigation of a broken bottle of thallous thallous /thal·lous/ (thal´us) of, pertaining to, or containing thallium. thallous chloride Tl 201 chloride that was later recycled and used in distributed product. The 483 noted that the "firm has not validated its filtration system for the removal of glass particles." According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the EIR EIR n. popular acronym for environmental impact report, required by many states as part of the application to a county or city for approval of a land development or project. (See: environmental impact report) , the inspection resulted from a consumer complaint received by the Chicago District on June 2, 2001. Investigator Jason Chancey wrote in his 483: "On 6/29/01, the glass bottle containing the bulk solution of thallous chloride imploded im·plode v. im·plod·ed, im·plod·ing, im·plodes v.intr. To collapse inward violently. v.tr. 1. To cause to collapse inward violently. 2. at the conclusion of the mixing process." The 483 added: "This imploded glass bottle also had multiple wall-to-wall fractures throughout its body and 'maintained its original shape as it was held in place by a PVC PVC: see polyvinyl chloride. PVC in full polyvinyl chloride Synthetic resin, an organic polymer made by treating vinyl chloride monomers with a peroxide. liner used to contain the solution should this type of event occur.' The PVC liner leaked." A Nycomed Amersham employee "wishing to remain anonymous," reported that a "multiple liter bottle of thallous chloride was dropped during the first shift" on June 29, 2001, and that the drug was "vacuumed off the floor, filtered, and subsequently used to fill finished product vials." Chancey reported there were no assurances the finished product was "free from glass particles" and that the firm did not "test finished product for particles and instead relies upon filtration and visual inspection for particle detection." The agency further criticized Amersham in its attempts to correct the problem. Chancey noted the firm's contacting a glass vendor in order "to see if an unbreakable type bottle can be purchased," and the consideration of a better bottle finer, "did not address the current need to prevent similar incidents from occurring in the near future." Amersham VP of Corporate Affairs Tracy Cheung told Validation Times in a phone interview that FDA had returned to re-inspect the plant in August 2001. Cheung said the incident concerning the bottle of thallous chloride had been deemed "an isolated one" and did not require a design or process change. Amersham Mediphysics, Arlington Heights, IL, 7/3, 6, 9, 10/01, Doc. 109347M, $5 plus retrieval. [check] The Checklist--Amersham Mediphysics [check] filtration system validation |
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