Warning Letter: Neil Laboratories

June 22, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

This week, the US Food and Drug Administration (Rockville, MD, www.fda.gov) posted a Warning Letter issued May 31 by its New JerseyDistrict Office (Parsippany, NJ) to Neil Laboratories (East Windsor,NJ, www.neillabs.com).The six-page letter cited Neil for five CGMP deviations, manufacturingeight drugs the agency called "unapproved new prescription drugs," andmaking four products FDA called "misbranded over-the-counter drugs."The company manufactures a variety of products, many of them includingguaifenesin,  psuedoephedrine, dextromethorphan, sennoside, andaspirin, alone or in combinations.

CGMP citations
In particular, based on two weeks of inspections at the end of December2005, the Warning Letter charged Neil with shortcomings current goodmanufacturing practice in:

  • establishing "scientifically sound and appropriatespecifications, standards, sampling plans and test procedures" toensure product identity, strength, quality, and purity [21 CFR 211.160(b)];

  • establishing a written stability testing program [21 CFR 211.166(a)(3)];

  • ensuring that computer and other systems permit changes to masterproduction and control records only by authorized personnel [21 CFR 211.68(b)];

  • maintaining complete laboratory testing records [21 CFR 211.194(a)].

  • ascertaining that supervisory personnel have proper "education,training and experience" [21 CFR§ 211.25(b)].


(The first two citations repeated observations included in an October2, 2001 Warning Letter issued to the company, FDA said.)