FDA Consumer

Faulty premix prompts infant formula recall

Faulty premix prompts infant formula recall – Investigators’ Reports

Dori Stehlin

Faulty Premix Prompts Infant Formula Recall

A manufacturer of infant formula premixes (mixtures of vitamins and minerals) has agreed to stop making and selling these products after investigators found premixes with the wrong level of ingredients and insanitary conditions in the manufacturing plant.

A premix with too much vitamin A and too little vitamin D triggered the investigation. Fortunately, the formula manufacturer who bought the premix discovered the problem during the quarterly testing required by FDA regulations under the Infant Formula Act of 1980 and recalled the formula. No injuries were reported.

The testing done by the formula manufacturer, Gerber Products Co., Fremont, Mich., revealed vitamin A levels in a meat base infant formula 20 percent above the maximum allowed by the Infant Formula Act. Gerber also analyzed the premix itself and found it had about 70 percent more vitamin A than stated on the certificate of analysis furnished by the premix manufacturer, Watson Foods Co., Inc., Woodside, N.Y. Gerber began a recall of the affected formula on Feb. 15, 1985, and told FDA. (Gerber has since canceled its account with Watson Foods.)

FDA inspected Watson Foods in February and March, 1985. Investigators easily pinpointed the reason behind the extra helping of vitamin A in the premix sold to Gerber. To speed production, two employees were assigned to the same batch. However, these two employees were apparently unaware of each other’s work, so they both added the specified amount of vitamin A. Because Watson’s chemist mistakenly prepared the vitamin A standard (a known amount of vitamin A) with twice the vitamin A called for, his comparison of the premix with the standard did not catch the production error.

The reason for the insufficient amounts of vitamin D was not as clear. Like the vitamin A, it was added twice to Gerberhs lot. How could there still be too little? One possible explanation was that Watson stocks two different concentrations of vitamin D–one much weaker than the one specified on the production instructions–and the employees may have used the weaker concentration. It would have been an easy mistake to make, since investigatiors found plastic bags of both concentrations of vitamin D stored in one drum. The low amount of vitamin D was not caught by the lab becuase it didn’t analyze the finished premix for that vitamin.

In addition to the manufacturing and laboratory testing problems, FDA investigators found insanitary conditions in Watson’s warehouse. They saw live mice and found rodent hairs, urine and exreta pellets both in and around the stored food. Also, many food products were either unlabeled or mislabeled.

When presented with these findings, John J. Watson, president of Watson Foods, promised to make all the changes necessary to comply with regulations. The firm did clean up the warehouse. But many of the same problems–plus some new ones–were found when FDA returned three months later.

Ross Laboratories, manufacturer of Similac and Isomil infant formulas, had just returned one lot of Watson’s mineral premix that contained too much zinc. Not enough vitamin D was just one of the many deficiencies in another lot of vitamin-mineral premix sold to Milupa Corp., a division of Beech-Nut Nutrition Corp.

Problems with Watson’s other food products, such as dough conditioners and prepared mixes for cakes and cookies, had occurred before. In April 1971, niacin was mistakenly substituted for cornstarch in a batch of Watson’s pie crust mix, and 60 people in North carolina became ill from the product.

Why didn’t Watson’s lab catch all these mistakes? One reason was that if Watson’s chemists analyzed a product and found incorrect nutrient levels they frequently ignored the results. Instead, they would base their nutrient level statements on the certificate of analysis on production records (the amount the employees were supposed to have added). Watson’s chief chemist called this an “analysis by audit” system. Investigators also found an assistant chemist who had no formal training in the tests he performed, so mistakes were easy.

Regulations allos infant formula manufacturers to rely on the premix manufacturer’s certificate of analysis. Therefore, it is crucial for companies such as Watson Foods to follow quality control procedures at all times. (FDA’s inspection of Ross Laboratories showed that Ross tests each batch of premix for each nutrient before it is added to the formula.)

FDA inspected Watson again in October 1985. The firm’s warehouse was still clean, but manufacturing and laboratory procedures had not improved.

On Dec. 27, 1985, the U.S. attorney for the Eastern District of New York filed a complaint against Watson Foods requesting a court order to stop the firm from preparing, packing, holding or distributing any food products until all areas of its operation comply with FDA regulations and until the firm can assure FDA that the proper manufacturing and testing controls are in place. On Feb. 12, Watson Foods entered into a consent decree of permanent injunction.

Because infant formula manufacturers have either recalled their products containing Watson nutrient premix or are testing those premixes themselves, FDA believes the formula currently for sale will not endanger infants’ health.

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