Today FDA released its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
LifeSouth Community Blood Centers Gainesville, FL (7/29). Inspected Montgomery, AL facility 3/12-21 and 4/2-7/03. Facility failed to permanently defer a donor who tested Rapid Plasma Reagin reactive as required by the facility’s written procedures. It also did not file Biological Product Deviation Reports on three units that represented a storage temperature deviation and two communicable disease hazards. Many of the records intended to document the control of critical operations at the firm are not adequately maintained or reviewed as required, etc. (blood center); FDCA 501(a)(2)(B), 21CFR 606.165(e), 606.171(b), 606.120(b)(3), 606.100(b)(c), 211.92, 640.25(b)(4), 606.160, 211.100, 211.192(a), 211.68(a), 211.22(a), 606.160 (03-NSV-20)
Fine, I. Howard Eugene, OR (7/25). Inspected 4/18/03. Clinical investigator violations: Investigator conducted research on human subjects without continuous IRB approval. There were discrepancies between the information recorded in source documents and the data recorded on case report forms. Device accountability records were incomplete in that many of the receipt records lacked signatures/dates and contained improperly documented changes. The return records consisted of photocopies containing obscured data and did not include the reasons for returning the lenses, etc. (device study); FDCA 520(g), 21CFR 812.100, 812.100(a)&(b), 812.140(a)(3), 812.140(a)(2) (No Code)
Ayoula Dublin New York, NY (7/22). Misbranded: Unapproved new drug: The injectable product does not qualify as a dietary supplement since it is not intended for ingestion. False promotional statements are being made on the Web site www.geocities.com/lipodissolve such as “It is made of a nutritional supplement lecithin, which does not fall under FDA’s jurisdiction, that’s why it’s legal to inject and sell Lipostabil…” (Lipostabil); FDCA 505(a), 503(b)(1), 502(a) (NYK-2003-30)