Warning Letter: Watson Labs

On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe,Inc. (Corona, CA) by FDA's San Juan (PR) district office. The Warning,dated June 19, cited manufacturing deficiencies at Watson'sHumacao, Puerto Rico facility. According to the letter, a Nov.3–Dec.15, 2005, FDA inspection uncovered significant deviations from currentgood manufacturing practice (CGMP) regulations including:

• The company's "inadequate" handling and identification of sievedmaterials could have caused an incorrect component or active ingredientto be used in the manufacture of drug products (21 CFR Part 211.80 [a]). The WarningLetter listed the mislabeling of the active ingredient, trazodone HClsalt, as lactose. The ingredient was then used during the manufactureof clindamycin HCl antibiotic capsules. The lots were rejected, butothers that were manufactured in the same equipment were released withonly minor cleaning.

• Laboratory controls did not include appropriate test proceduresto ensure in-process materials and drug products conform to identity,strength, quality, and purity standards (21 CFR Part 211.160[b]). For example,the letter noted that numerous changes were made to the dissolutiontesting process of the "Reclipsen" oral contraceptive within one yearwithout additional validation. The letter said FDA has "no assurancethat the current method is able to consistently produce precise andaccurate results."

FDA recommended Watson Laboratories, "take prompt action to correctthese violations, and you should establish procedures whereby suchviolations do not recur. Failure to do so may result in regulatoryaction without further notice, including seizure and/or injunction."