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This article was originally published in The Tan Sheet

Executive Summary

AMBIX LABS' DRUG SEIZURE INCLUDES OTC HYDROCORTISONE CREAM that tested positive for Staphylococcus Aureus. Following a complaint filed by FDA on July 28, U.S. marshals later that day seized all finished prescription and over-the-counter drugs manufactured by East Rutherford, N.J.-based Ambix Laboratories. A producer of Rx and OTC private label creams, gels and liquids, Ambix was ordered to halt all operations until its facilities and operations are brought into compliance with FDA regulations, according to the agency complaint. FDAers did not put a value on the seized goods. During a March inspection of Ambix facilities, FDA discovered that the company "manufactured and released for distribution [one] lot of hydrocortisone cream .5% which had tested positive for Staphylococcus Aureus," a bacterium arising from skin infections, sewage and feces, and insects, the complaint explains. Ambix "failed to conduct an investigation to establish why the lot of hydrocortisone cream .5% tested positive" for the bacterium, FDA said. In related findings, Ambix "discovered rodent and insect activity in its facility" and "documented a filling machine as being contaminated with insects as well as an unspecified Staphylococcus," FDA said. The agency noted that the company had not established cleaning procedures for the filling machine. During a follow-up inspection by FDA in June, the agency observed that Ambix "continued to deviate significantly" from current good manufacturing practices. The second inspection found that the manufacturing and testing environment was "not maintained in a clean and sanitary condition" and that the pharmaceutical manufacturing and laboratory areas contained "uncovered drums of materials." Other CGMP violations found during the June follow-up inspection included: "dried ointment-like material splattered on ceiling light fixtures"; "water-stained, soiled and loose ceiling tiles"; "soiled and paint-chipped floors"; "puddles of water on the floor"; and "instruments which measure quality control covered with dirt, an oily residue and/or particulate matter," according to the FDA complaint. Also during the follow-up inspection, FDA found that "Ambix failed to investigate product specification failures." For example, the agency "discovered that on or about May 25, 1993, Ambix Laboratories produced about 800 pounds of aloe vera first aid cream with a double dose of active ingredient, and there has been no formal written investigative report on this product failure." Among other deficiencies mentioned by FDA in the suit are that Ambix "failed to validate cleaning procedures for its equipment" and did not generate "meaningful or accurate data by the accelerated stability program for product samples." Ambix also had not instituted validation procedures, FDA charged, for stability testing methodologies; assay methodologies; the facility's de- ionized water system; the pressure cooker used for sterilization of media and lab equipment; finished product testing; and the company's manufacturing processes in general. In addition, FDA cited the firm for not validating the "accuracy, sensitivity, specificity and reproducibility of its microbiological test methods and established methods." The agency pointed out, for instance, that one lot of phenylephrine HCl "was challenged with Salmonella. Ambix failed to follow its own procedure in that the broth utilized in producing the product was incubated for three days instead of 24 hours." Ambix Labs also "failed to investigate product complaints and/or produce written reports of investigations of product complaints," FDA asserted, citing a situation with the firm's kaolin/pectin oral suspension. On June 11, FDA said it received a phone call complaining that bottles of the kaolin/pectin product were "bulging" and that the company had been apprised of the problem. However, FDA noted, "no action was taken by Ambix Laboratories until it was contacted by the FDA regarding the problem" around June 23. After a recall of the kaolin/pectin suspension around June 25, FDA "tested the kaolin/pectin oral suspension in the bulging bottles and found that it was contaminated with yeast and contained a gram negative bacteria, Enterobacter Gergoviae, which has been associated with urinary tract infections." The agency noted that microbiological testing for the kaolin/pectin product conducted by Ambix "failed to detect either yeast or bacterial contamination of the product," according to the agency suit. In justifying the seizure action, FDA asserted in the complaint that Ambix Labs has had a long history of noncompliance with agency regulations going back to 1976. According to a summary of the complaint issued by the U.S. Attorney for New Jersey, "since 1976, Ambix has been subject to FDA regulatory actions, warnings and meetings, as well as a prior seizure for its failure to conform" to CGMPs "and has assured the FDA on numerous occasions that it would bring its operations into conformance with CGMPs." Problems cited by FDA in the past include "release of subpotent drugs, inadequate testing, incomplete and inaccurate laboratory records and procedures, and inadequate cleaning procedures," the U.S. Attorney summarized. FDA's Newark District Office developed the case against Ambix, which is represented in the suit by Co-owner and President Alvin Goren and Co-owner and VP Eli Gorenberg. The federal government is represented by Assistant U.S. Attorney Michael Chagares of the U.S. Attorney's Civil Division in Newark, N.J. The case has been assigned to U.S. district Judge Lee Sarotin. No court dates have yet been set.

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