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US Regulators Warn P & G Over Problems at Puerto Rico Plant

By Pharmaceutical Processing | May 5, 2009

MIKE MELIA Associated Press Writer SAN JUAN, Puerto Rico (AP) — U.S. regulators warned Procter & Gamble Co. over unsanitary conditions at a plant that makes Olay skin care products and Vicks cold medicine in Puerto Rico, according to a letter released Tuesday. The warning letter from the Food and Drug Administration said problems at the Olay LLC plant in Cayey may have caused contamination or threatened the health of consumers. It faulted failures in following procedures for cleaning maintenance equipment. An inspection found over-the-counter drug products have been “prepared, packed and held under unsanitary conditions whereby they may have been contaminated with filth or rendered injurious to health,” said the letter. Paul Fox, a spokesman for Cincinnati-based Procter & Gamble, said none of the issues raised by the FDA compromised the safety of any products. But he said FDA inspectors did identify areas “where we can and will make improvements,” and the company has begun a review of the plant’s manufacturing practices. The FDA letter, dated April 24, described violations that inspectors found between August and November 2008. It told the company to respond within 15 days with a plan to bring the plant in line with federal regulations. Among other problems the letter cited the plant for not investigating evidence of possible contamination, including “health effect-related complaints” for its Vick Sinex product. Procter & Gamble, which has about 700 employees in this U.S. Caribbean territory, said last month it was cutting about 90 part-time jobs at the plant in the central town of Cayey as part of a broader restructuring.

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