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Latest FDA Warning Letters

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Coram Healthcare Corporation of Indiana dba Coram CVS/Specialty Infusion Services Crown Point, IN (8/11). Inspected 12/1-16/14. Violations, adulterated: The operator’s gloves were not always appropriately sanitized with sterile (purged) before the operator’s gloved hands were placed under the ISO 5 laminar flow hood. The firm failed to demonstrate through appropriate studies that the hood is able to provide adequate protection of the ISO 5 area in which sterile drug products are produced, etc. (sterile drug products); FDCA 501(a)(2)(A)(B)

Jaychem Industries, Ltd. Auckland, New Zealand (9/4). GMP deviations, adulterated, misbranded: The company failed to ensure the quality of components. It also failed to establish adequate written control procedures to monitor (purged) during manufacturing and it stated that the company released all (purged) lotions regardless of (purged) results. The labels for GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm state that they are intended to prevent sunburn. Therefore, they are drugs as defined because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man. They are subject to among other regulations the OTC sunscreen drug products monograph and required labeling based on effectiveness testing. The lotion and lipbalm are also misbranded because Broad Spectrum and SPF 30 appear separately and in different font sizes on the products’ principal display panels, etc. (GolfersSkin SPF 30 Plus WR80 Sunscreen Lotion (4.2 fl oz) and GolfersSkin SPF 30 Plus Sunscreen Lip Balm); FDCA 501(a)(2)(B), 502(a)&(c), 502(f)(1)&(2), 502(f)(2), 21 CFR 211.84(d)(1) and (2), 211.110(a), 211.165(a), 211.166(a)

Pan Drugs Ltd. Gujarat, India (9/2). Inspected 7/14-18/14. GMP deviations, adulterated: The firm failed to properly maintain, repair, and keep clean buildings used in the manufacture of APIs in a manner that prevents contamination where open equipment is used. For example, the investigator observed holes in the walls and roof which allowed pigeons access near production equipment in multiple manufacturing areas and gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building. The investigator also observed rust, dirt, lubrication leaks, and exposed insulation material on and around open drug manufacturing equipment. The firm failed to maintain complete data derived from all testing and to ensure conformance with established specifications and standards, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)


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