Warning Letter Cites Inadequate Lab Controls at Illinois-based Lab

Warning letter was focused on Illinois firm’s lab controls.

Inadequate lab controls were cited in a July 25 warning letter issued to Pharmaceutical Labora­tories and Consultants Inc. in Des Plaines, Ill.

The letter is another signal that FDA investigators are continuing to focus attention on data integrity and related concerns about the accuracy of testing data.

Inadequacy of lab controls is a major compliance issue in New Jersey as well, according to a New Jersey District FDA official, Nancy Rolli (see story, p. 13).

During an inspection conducted from April 16 to May 3, FDA found that the firm, which is a contract testing laboratory for prescription and OTC drugs, was in violation of 211.160(b) for "failure to establish laboratory controls that include a deter­mination of conformance to scientifically sound and appropriate specifications, standards and test pro­cedures designed to assure that drug products con­form to appropriate standards of identity, strength, quality and purity."

For example, FDA investigators determined that the firm had incorrectly calculated assay test results for 12 batches of product.

FDA Chicago District Director Scott MacIntire wrote that "when the results were re-calculated with the required conversion factor, approximately six of the 12 batches were out of specification. At the end of the establishment inspection, your firm had yet to inform the product distributor of these material findings."

Related to this area, FDA also found that the firm failed to follow the microbial limits testing procedure specified in the USP monograph. The firm's testing procedure analyzed a single sample aliquot preparation, whereas the USP monograph specifies analyzing duplicate aliquots of sample preparations.

The field office also found that the firm failed to verify the suitability of the chromatographic system it used in the assay testing of menthol for several of its products.

FDA also found that the firm was in violation of 211.165(e) governing testing and release when it failed to validate four of the firm's most frequently performed analytical test methods used to assay the drug products' active ingredients.

The third major compliance issue cited in the letter, and a problem area Rolli highlighted is in the area of laboratory records at 211.194(a). The warning letter said that the firm failed to record the raw data for the preparation and testing of growth media used in the microbiological testing of drug products.

- Joanne S. Eglovitch ([email protected])