DG Labs dba 7-Day Miracle Cleanse Burbank, CA (7/22). Unapproved device, misbranded: Firm’s device, the Colon Board, appears to FDA to be an enema kit, but the intended use of the device as reflected by claims on the company Web site more closely resembles those for a colonic irrigation system for routine colon cleansing. (Colon Board); FDCA 501(f)(1)(B), 502(o), 510(k), 510(j), 21 CFR 876.5210, 876.5220(b)(2) (No Code)
http://www.fda.gov/foi/warning_letters/g4887d.pdf
Johnson, Miers Nampa, ID (8/2). Inspected 3/22-26/04. Deviations: Investigator failed to conduct the investigation according to the signed agreement with the sponsor, the investigational plan, and any conditions imposed by the IRB. For example, Johnson failed to exclude subjects from the study who met the exclusion criteria identified in the protocol. He also failed to submit amendments to the protocol dated 5/8/02 and 6/17/02, involving changes to the study inclusion and exclusion criteria, to the reviewing IRB. A (purged) number of subjects signed documents that had significantly different language than the IRB approved versions on the opening page. Investigator failed to submit progress reports to the sponsor, etc. (investigational study); 21CFR 812.100, 812.110(b), 812.100, 50.27(a), 812.150(a)(3) (No Code)
http://www.fda.gov/foi/warning_letters/g4879d.pdf
Kim, Hyun S. Kevin Baltimore, MD (7/30). Clinical investigator violations: Investigator failed to submit a report of two unanticipated adverse device effects to the sponsor and the IRB. For example, a subject reported an event of dysuria requiring catheterization in the emergency room to the site on 1/30/03, but the event was not reported to the sponsor and the reviewing IRB in accordance with the regulation. He also failed to obtain informed consent from eight out of (purged) subjects prior to their participation in the study, etc. (device study); 21CFR 812.150(a)(1), 50.20, 812.100, 812.140(a)(3)(i)(ii), 812.100, 812.140(a)(2)(ii) and (iii), 812.140(a)(3) (No Code)
http://www.fda.gov/foi/warning_letters/g4880d.pdf
Mar, Timothy P. Sacramento, CA (7/28). Inspected 3/1-16/04. Investigator violations: Investigator failed to ensure informed consent was obtained from all study subjects and failed to follow the Investigator’s Agreement, Investigational Plan, and applicable FDA regulations. He also failed to obtain IRB approval prior to initiating the study, etc. (device study); 21CFR 812.110, 812.100, 50.20, 50.25(a)(1), 50.27(a), 812.150(a)(1), 812.140(a)(2)(3) (No Code)
http://www.fda.gov/foi/warning_letters/g4883d.pdf
Pharma Fab Grand Prairie, TX (6/15). Inspected 1/5-14/04. GMP deviations, adulterated: The Quality Control Unit failed to review and approve drug product production and control records to determine compliance with all established approved written procedures before a batch is released or distributed. For example, the purified water USP from 12/19/03 failed to meet microbiological specification with too numerous to count values (TNTC) reported, yet the water from that day was used to manufacture (purged) a (purged) lot. Tubing used to transport water into the transport tank was placed into a poly bag with residual moisture inside which violated Pharma Fab’s requirement to store tubing in a manner to facilitate complete drainage and drying as required, etc. (cough and cold prescription drug products); FDCA 501(a)(2)(B), 21CFR 211.192, 211.113(a), 211.100(b), 211.115(a), 211.166(a)(b), 211.180(e)(2), 211.67(a) (2004-DAL-WL-19)
http://www.fda.gov/foi/warning_letters/g4897d.pdf
SinTea Biotech Baranzate (Milano), Italy (8/2). Inspected 3/18/04. QSR deviations, adulterated: Company failed to establish and maintain corrective and preventive action procedures. It also did not establish and maintain procedures for evaluating complaints to determine whether they are required to be reported to FDA. SinTEa did not develop, maintain, and implement written MDR procedures, etc. (orthopedic devices such as the Traumafix System); FDCA 501(h), 21CFR 820.100(a)(1), 820.198(a)(3), 820.198(c), 820.30, 803.17 (No Code)
http://www.fda.gov/foi/warning_letters/g4878d.pdf
Tenacore Holdings Inc. Santa Ana, CA (7/26). Inspected 5/17-24/04. QSR deviations, adulterated: No quality plan defining the quality practices, resources, and activities relevant to devices that are designed and manufactured has been established or implemented. Company did not establish procedures for implementing corrective and preventive action. It did not maintain the device master record for repacking and relabeling specifications, including methods and processes used, etc. (Pulse Oximeter probes, Ultrasound, Teco transducers); FDCA 501(h), 21CFR 820.20, 820.198, 820.181(d), 820.150(a), 820.80, 820.22, 820.50 (W/L 34-04)
http://www.fda.gov/foi/warning_letters/g4885d.pdf
Vintage Pharmaceuticals, Inc. Huntsville, AL (5/26). Inspected Charolotte, NC facility 3/29-4/2/04. Deviations: Company had never submitted an adverse drug experience (ADE) to FDA, including any 15-day alerts, quarterly reports, or annual reports for any application. Vintage’s complaint procedure does not address the identification and handling of ADE reports. FDA investigators found several experiences in the company complaint log that should have been reported under the ADE requirements, etc. (drugs); FDCA 505(k)(1), 505(j), 21CFR 314.80 (04-ATL-10)
http://www.fda.gov/foi/warning_letters/g4901d.pdf
Z Cosmetica USA, LLC Farmingdale, NY (6/28). Inspected 3/5-19/04. GMP deviations, adulterated: The firm does not test or examine each lot of components, drug product containers or closures. It also does not test each batch of drug product to determine conformance with final specifications. There are no written standard operating procedures for component controls, production and process controls, labeling and packaging controls, and laboratory controls. Also process validation has not been conducted for any of the firm’s drug products. The firm does not collect stability samples or test the stability of their drug products, etc. (hydrocortisone cream, benzyl peroxide gel, salicylic acid gel, hydroquinone cram, and coal tar shampoo); FDCA 501(a)(2)(B), 21CFR 211.84(d), 211.165(a), 211.100(a), 211.166(a)(b), 211.113(a), 211.67(b), 211.22, 211.182, 211.188, 211.110(c), 211.101(a), 211.122(d), 211.105(a)(b), 211.180(e), 211.170(a) (NYK-2004-20)
