Polychrome Medical Brooklyn Center.MN, Dec. 7 (Minneapolis) An inspection Aug. 14-20 found the company, which manufactures CF (Cystic Fibrosis cystic fibrosis (sĭs`tĭk fībrō`sĭs), inherited disorder of the exocrine glands (see gland), affecting children and young people; median survival is 25 years in females and 30 years in males. ) Indicator Sweat Test sweat test Pediatrics A test used to diagnose cystic fibrosis–CF, which is characterized by defects in secretion–especially of sodium and chloride–by exocrine glands. See Cystic fibrosis. Cf Sweat testing. Systems, not in conformity with GMPs. The inspection revealed failure to maintain device master records that are prepared and approved in accordance with the QS regulations. A review of batch records from the last two years of production for the Cystic Fibrosis Indicator Sweat Test System showed that the company has not followed a Device Master Batch record. It was unclear how much of each raw material was added, what specifications were followed, and identity of the individual conducting the manufacturing. The company also failed to develop, conduct, and monitor production processes to ensure that a device conforms to its specifications. The company lacked documentation of quality assurance acceptance or review throughout the manufacturing process from receiving, production, testing and final packaging, to final release of this device. There were 34 CF Indicator Sweat Test units placed into quarantine quarantine (kwŏr`əntēn), isolation of persons, animals, places, and effects that carry or are suspected of harboring communicable disease. due to failures or returned product. The company failed to document the analysis of quality data and investigation of the cause of the nonconformities. The agency also noted the company's failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mixups, specifically to the failure to document the correct lot numbers of the raw materials used to manufacture the Pilocarpine pilocarpine (pīlōkär`pēn), naturally occurring alkaloid obtained from plants of the genus Pilocarpus (family Rutaceae). Interface pads, Chloride concentration test patches, and Potassium Sulfate potassium sulfate n. A colorless or white crystalline compound, K2SO4, used in glassmaking and fertilizers and as a reagent in analytical chemistry. Interface Pads, all of which were part of the CF Indicator Sweat Test System. The company was cited for its failure to test or establish test specifications for the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. Pilocarpine Nitrate 1% that is used as an ingredient in the manufacturing of the test kits that are part of the Sweat Test Indicator System. In addition, the company had not developed and implemented procedures for acceptance or rejection of finished Sweat Test Kits prior to distribution. For example, there was no documentation of quality assurance testing in the batch lots reviewed between 1/1/07 and 8/14/07. The firm also does not have written, corrective and preventive action Corrective and Preventive Action (CAPA) is a concept within Good Manufacturing Practice (GMP). CAPA focuses on the systematic investigation of discrepancies (failures and/or deviations) in an attempt to prevent their reoccurrence. procedures, as required. 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. further noted that the company has failed to document corrective and preventive action activities, including analysis of sources of quality data, investigations of causes of nonconformities, the actions needed to correct or prevent recurrence of nonconforming product and other quality problems, the verification or validation of corrective actions, and implementation of corrective and preventive actions. As of January 2007, the firm changed the design of a component of the CF Indicator Sweat Test System due to customer complaints of device failures, but failed to document the verification or validation of the design change. CAPA CAPA California Alternate Performance Assessment CAPA Captaris, Inc (stock symbol) CAPA Confederation of Asian and Pacific Accountants CAPA Creative and Performing Arts (school) ; QC/QS |
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