Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
Six companies are marketing products that contain analogs of sildenafil, the active pharmaceutical ingredient in Viagra. Unapproved new drugs.
Access Financial Market, Bloomington, MN
Actra-Rx, Beverly Hills, CA
ATCSF Inc. San Francisco, CA
Herbn Tonics, Beverly Hills, CA
Herbal Remedies, Casper WY
Sargent, Robert Batavia, NY
Advanced Medical Systems Birmingham, AL (7/13). Inspected 2/14. Unapproved Class 3 devices, adulterated, misbranded (catheters); FDCA 501(f)(1)(B), 515(a), 520(g), 510(k), 502(o) (2006-NOL-13)http://www.fda.gov/foi/warning_letters/g5922d.pdf
Good, Cheryl Guntersville, AL (7/12). Unapproved new drugs, misbranded: Products are offered for diseases or conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Adequate directions cannot be written so a layman can use these products safely for their intended uses, etc. (RAE’lex Circulation Formula, RAE’lex Wound Gel, and RAE’lex Lotion); FDCA 502 (f)(1), 505(a) (2006-NOL-12)http://www.fda.gov/foi/warning_letters/g5921d.pdf
Parnell Pharmaceuticals San Rafael, CA (7/10). Uncleared device, adulterated, misbranded: FDA responds to a 3/7 company letter claiming that the product MouthKote is not a medical device as described by FDA in a 2/27 letter, but a cosmetic device. FDA believes the device is clearly intended for use as a saliva substitute. (MouthKote Oral Moisturizer); FDCA 501(f)(1)(B), 502 (o) (No Code)http://www.fda.gov/foi/warning_letters/g5920d.pdf
Stachniw, Myron Galesburg Orthopedic Services, Ltd. Galesburg, IL (7/6). Inspected 3/20-4/5. Clinical study violations: Investigator allowed subjects to participate in the study prior to receiving FDA and IRB approval. He also failed to obtain proper informed consent prior to any study-related procedures. The investigator did not submit complete, accurate, and timely progress reports to the IRB, etc. (device study); 21CFR 812.110(a)&(b)&(c), 812.100, 50.20, 812.150(a)(3)&(5), 812.140(a)(2) (No Code)http://www.fda.gov/foi/warning_letters/g5919d.pdf
Watson Laboratories Caribe, Inc. Corona, CA (6/19). Inspected Humacao, PR plant 11/3-12/15/05. GMP deviations, adulterated: Company failed to handle and store components and drug product containers in a manner to prevent contamination. Laboratory controls do not include establishment of scientifically sound and appropriate test procedures. For example, in 2/05 aberrant and OOS results were obtained during dissolution testing of Reclipsen. The company investigation found that the validated method was flawed due to physical-chemical interaction between the active ingredient and the approved dissolution media. Several changes were made, but there is no assurance that the current method is able to consistently produce precise and accurate results, etc. (Reclipsen, Trazodone HCl, Clindamycin HCl capsules, etc.) FDCA 501(a)(2)(B), 21CFR 211.80(a), 211.160(b) (SJN-06-10)http://www.fda.gov/foi/warning_letters/g5918d.pdf