Celsus Laboratories Cincinnati, OH (11/12). Inspected 1/9-3/13/02. GMP deviations, adulterated: Firm’s stability program is insufficient in that samples are not tested at the established frequency, results are not correctly compared against specifications, stability sample container/closures are not equivalent to the containers used for marketing, and investigations of aberrant results are not fully investigated and in consideration of already marketed products. The firm’s cleaning procedure for product contact equipment surfaces has not been shown capable of reducing microbial and endotoxin contamination to acceptable levels. Water used in processing active ingredients has been found at times to have unusually high endotoxin levels in testing Celsus has performed, but the firm did not properly respond to the atypical results at the time they were detected, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B) (CIN-03-13127)

http://www.fda.gov/foi/warning_letters/g3716d.pdf

Pinson’s Fitness Products Cincinnati, OH (11/19). Unapproved new drugs: Products cannot be dietary supplements because they are not intended for ingestion because they are topical, sublingual or intra-nasal products that are intended to bypass the alimentary canal by direct absorption through the skin, oral or nasal mucosa. Further, all transdermal drug delivery products are new drugs because of the newness of the dosage or method or duration of administration or application suggested in the labeling (Pharmalogic XRX Intra-Oral Androgenix Spray, Primavar SCC Sublingual Tablets, Test-4 Blast, Deca Derm, and Dermadrol); FDCA 505 (CIN-03-15775)

http://www.fda.gov/foi/warning_letters/g3718d.pdf