Human drugs

Warning Letter Bulletin, August 26, 2002

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GHMedical.com, Hallandale, FL, June 29 (Florida). Claims made by the company on its Web site have misbranded its Saizen 5 mg., 15 IU. [somatropin (rDNA origin) for injection] recombinant growth hormone, the agency stated in the warning letter. While Saizen does have an NDA, FDA added the drug "is approved for one indication only, namely for the long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone." On its Web site, the company claimed Saizen could be used for "hormone rejuvenation therapy ... improved skin texture ... greater bone density ... increased time for healing. ... increased immunity and resistance to infection ... increased libido" and many other unapproved uses, FDA stated. The agency also called the product misbranded in that "its labeling fails to bear adequate directions for the uses for which it is being offered," the letter continued. Lab, NDA, Web

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Medpointe Healthcare, Inc., Somerset, NJ, July 22 (New Jersey). Medpointe was cited for failing to "thoroughly investigate and implement corrective actions for the presence of black specks, containing metal particles" on the firm's Soma (carispordol) 350 tablets. FDA also took issue with the fact Medpointe had no documented health hazard evaluation for the presence of metal in the product. The three-page warning letter cited the firm for having an inadequate inspection system "to cull out rejected tablets," for not having documentation to demonstrate that metal detectors were qualified for their intended use, and for not documenting maintenance on tablet compressors since 1995. While a June 25 response from the company maintained the black specks were primarily an aesthetic issue, FDA disagreed, stating it was not acceptable "to have visually observable contaminants" in the finished product. Also, the agency rebuffed a company response suggesting that the specks were leaked lubricant from tooling equipment and that it would replace seals in the equipment, citing that the company had not provided "an approved final report with a plan to correct the problem." Unnamed investigators inspected the Cranbury, NJ, drug manufacturing site May 20-June 6. QC/QS

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Wallace O'Farrell, Inc., Puyallup, WA, Aug. 7 (Seattle). A June 21 and 24 inspection of the facility by investigator Carl Anderson found "significant deviations from legal requirements in the procedures used to manufacture" its OTC personal lubricant "Slippery Stuff." The 10-item warning letter cited the firm for not having written production and process control procedures for charge-in of components, calculation of yield, equipment identification, sampling and testing of in-process materials and drug products, and control of microbiological contamination. Additionally, the company was hit with not having reviewed and approved gel formulating records, not having cleaning and sanitation records for equipment, and not having written procedures for stability testing and assuring that correct labels were used for its drug products. Lab, Stab, QC/QS