LNK International, Inc. It manufactures solid dose, over-the-counter pharmaceuticals in the pain relief, cough and cold, aspirin, allergy and gastro-intestinal categories. The company was founded in and is headquartered in Hauppauge, NY.
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Address how your firm will ensure all phases of investigations are appropriately conducted. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity 21 CFR You failed to establish sufficient specifications and analytical testing procedures for critical quality attributes for the drugs you manufacture.
You often lacked specifications or analytical testing procedures for dissolution, and also failed to test for the impurity 4-Aminophenol in acetaminophen-containing drug products. For example, at least four acetaminophen and diphenhydramine combination solid oral dosage form drug products and three acetaminophen and phenylephrine HCl combination solid oral dosage form drug products lacked specifications or analytical testing procedures for dissolution and 4-Aminophenol content.
In your response, you committed to validating analytical methods to detect and quantify 4-Aminophenol tests. You manufacture more than b 4 additional solid oral dosage forms that contain acetaminophen as an active ingredient, but it is unclear if you assessed all acetaminophen-containing finished drug products for 4-Aminophenol testing criteria.
You also committed to b 4 for a number of solid oral dosage forms including those that contain acetaminophen and diphenhydramine HCl as well as acetaminophen and phenylephrine HCl. Provide the date by which a CAPA will be implemented. Provide status of all testing that has been done to date and detailed testing data. Specify any in-date lots that have not yet been tested. Determine whether each lot conforms to all appropriate specifications, including but not limited to dissolution and impurities.
Provide specific timelines for expeditiously completing this testing and a commitment to take prompt action, including customer notifications and recalls, in the event of any failing tests. The assessment should also include, but not be limited to: o A determination of whether procedures used by your firm are robust and appropriate o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.
Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a consultant qualified as set forth in 21 CFR Violations cited in this letter are not intended as an all-inclusive list.
The proposed consent order contains a provision that is designed to remedy the charges and to prevent the respondent from engaging in similar acts and practices in the future. Part I of the proposed order prohibits LNK from misrepresenting the extent to which any non-prescription drug product containing an analgesic is made in the United States. The order defines "analgesic" as an agent used to alleviate pain. The proposed order would allow LNK to represent that such products are made in the United States as long as all, or virtually all, of the ingredients or component parts of such products are made in the United States and all, or virtually all, of the labor in manufacturing such products is performed in the United States.
The proposed order also would allow LNK to represent that a product containing imported active ingredient s is "Processed in the United States with Foreign Ingredients" when describing a product that has been "significantly processed" in the United States. The draft order also includes a provision that would allow LNK to use its current packaging inventory until December 31, Part II of the proposed order requires the respondent to maintain materials relied upon in disseminating any representation covered by the order.
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