Warning Letter Bulletin

Browse past and current articles from this publication.

Rymed Technologies, Franklin, TN, Feb. 9 (Dallas, TX).(MEDICAL DEVICES)
An Oct. 18-Nov. 8 inspection of the manufacturer and marketer of the Invision-Plus Neutral I.V. Connector Models and catheter extension sets found the products were not in conformance with the Quali . . .

Newport Medical Instruments, Costa Mesa, CA, Feb. 21 (Irvine, CA).(MEDICAL DEVICES)
The manufacturer of ventilators was determined to be not in compliance with current GMPs of the Quality Systems regulation. First, the firm failed to establish and maintain plans that define the r . . .

Medical Concepts Development, Woodbury, MN, Feb. 2 (Minneapolis, MN).(MEDICAL DEVICES)
The manufacturer of surgical drapes was inspected Oct. 25-Nov. 8, and was determined to not be in line with current GMPs. Deficiencies included failure to implement procedures for CAPAs. Specifica . . .

GE Healthcare Technologies, Waukesha, WI, Feb. 22 (Cincinnati, OH).(MEDICAL DEVICES)
FDA found that the manufacturer of coils used in magnetic resonance imaging systems and breast biopsy plates was not in full conformance with current GMP requirements of the Quality Systems regulati . . .

Fisher & Paykel Healthcare, Irvine, CA, Feb. 2 (Irvine, CA).(MEDICAL DEVICES)
An Oct. 25-Dec. 6, 2006 inspection found that the assembler of radiant infant warmers and neo-natal accessory products were not in conformance with current GMP requirements of the QS regulations for . . .

Edwards Life Sciences, Irvine, CA, Feb. 5 (Irvine, CA).(MEDICAL DEVICES)
An April 5-Aug. 10, 2006, inspection determined that the investigators from FDA determined that the manufacturer of the Swan-Ganz Continuous Cardiac Output (CCO) Catheter was not in conformance with . . .

Cephalon, Frazer, PA, Feb. 27 (Rockville, MD).(DDMAC PROMO UNTITLED LETTERS)
FDA warned that the company's marketing piece that recommended uses for Provigil (modafinil) Tablets [GIV] (Provigil) had not been reviewed or approved by FDA. The agency stated that the marketing . . .

Vintage Pharmaceuticals, Huntsville, AL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The company's Bellaspas Tablets were determined to no longer be covered by a current NDA. The firm was advised that it would need to apply for another NDA to continue to sell this product. Further . . .

United Research Laboratories and Mutual Pharmaceutical Company, Philadelphia, PA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY
The company's Bel-Tab tablets were found to contain ergotamine tartrate, which is used to treat vascular headaches, including migraines and migraine variants. The firm was advised that it would ha . . .

Superior Pharmaceuticals, Cincinnati, OH, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA wrote that the company's Migracet-PB Suppositories contained ergotamine tartrate, which meant that the firm would have to apply for an NDA to continue to sell the product. The agency also foun . . .

SDA Laboratories, Greenwich, Connecticut, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
This firm was sent a letter stating that its manufacture of Ergocaff PB suppositories was no longer covered by a current NDA, and that the company would need to apply for another one. The agency s . . .

Sandoz, Princeton, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The letter stated that the firm was a manufacturer of phenobarbital, ergotamine, and belladonna tablets, which contain ergotamine tartrate. This ingredient is not covered by a current NDA. The age . . .

Qualitest Pharmaceuticals, Huntsville, AL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The drug company's Ballaspas Tablets were found by the agency to contain ergotamine tartrate, an ingredient used to treat vascular headaches and no longer covered by a current NDA. The firm was ad . . .

Nucare Pharmaceuticals, Orange, CA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The letter stated that the company's Bellamine S Tablets, a drug product containing ergotamine tartrate used for treating vascular headaches, was determined by FDA to be a new drug and required an N . . .

Niagra Pharmaceuticals, Flamborough, Ontario, Canada, Feb. 23 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The firm, a manufacturer of an eyewash solution that contains purified water, was determined to have deviated from GMPs covering the manufacture of sterile drug products. For example, the company' . . .

Murfreesboro Pharmaceutical Nursing Supply, Murfreesboro, TN, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The company's drug products containing ergotamine tartrate, specifically, Bellamine S Tablets and Eperbel S Tablets, were found by FDA to no longer be covered by a 1962 NDA and would need another fo . . .

Lini, Rahway, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA stated that the company's Bell Phen Ergot S Tablets, Bellaspas Tablets, and Bellamine Tablets drug products contained ergotamine tartate and would require an NDA to be marketed for sale. These . . .

Kaiser Foundation Hospitals, Livermore, CA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA determined that the firm was marketing Belladonna Alka/Ergotamine and PB (Bellamine S) tablets, a drug product containing ergotamine tartrate. According to FDA, the drugs are utilized to treat . . .

Ivax Pharmaceuticals, Miami, FL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA warned the company regarding its marketing of Bel-Phen-Ergot S Tablets, a drug product containing ergotamine tartrate. This product is used to treat vascular head aches and previously was market . . .

Harvard Drug Group (formerly Major Pharmaceuticals), Livonia, MI, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The letter advised that the company's drug products contained an ingredient--ergotamine tartrate--used to treat vascular headaches, but the product was approved for safety only prior to 1962. The . . .

Ferndale Laboratories, Ferndale, Ml, Feb. 26, 2007 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The company, a manufacturer of drug products containing ergotamine tartrate, specifically, phenobarbital, ergotamine, and belladonna tablets, Bellamine Tablets, and Spas trin Tablets, was informed b . . .

Excellium Pharmaceutical, Fairfield, NJ, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The firm's Eperbel S Tablets, a drug product containing ergotamine tartrate for the treatment of vascular headaches, was determined to need an NDA to continue to be marketed for sale. Drug products . . .

DSC Laboratories, Muskegon, Ml, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The agency warned the firm regarding its drug products containing ergotamine tartrate, specifically, caffeine ergotamine, and pentobarbital suppositories and Bellcomp PB suppositories, for the treat . . .

DRX Pharmaceutical Consultants, Skokie, IL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The company was informed that its Bellamine S Tablets, a drug product containing ergotamine tartrate, to treat vascular headaches, must have a current NDA to be sold legally because the drugs were a . . .

Centrix Pharmaceutical, Birmingham, AL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The letter stated that the company's Ergocaff PB Suppositories, a drug product containing ergotamine tartrate for treatment of vascular headaches, were approved for safety only before 1962 and that . . .

Breckenridge Pharmaceutical, Boca Roton, FL, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The company's Spastrin Tablets and Bellcomp-PB Suppositories drug products used in the treatment of vascular headaches were determined to contain ergotamine tartrate, which the agency stated needed . . .

Bio Pharm, Levittown, PA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA said the firm's products containing ergotamine tartrate, specifically, Migracet-PB Suppositories and Ergocaff PB Suppositories, were marketed under new drug applications approved for safety only . . .

BioForm Medical, San Mateo, CA, Feb. 15 (Minneapolis, MN).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
The manufacturer of products to treat acne and eczema was inspected Oct. 2-18, 2006, where FDA investigators determined that the products were drugs because of the company's claims in its labeling, . . .

Anabolic Laboratories, Irvine, CA, Feb. 26 (Rockville, MD).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
FDA stated that the firm's drug products Bel Phen Ergot S Tablets, Bel-Tabs tablets, Cafatine PB Tabs tablets, Bellamine Tablets, Spastrin Tablets, and Urkaf-PB Tablets containing ergotamine tartrat . . .

Actavis Totowa, Little Falls, NJ, Feb. 1 (Parsippany, NJ).(HUMAN DRUGS & DIETARY SUPPLEMENTS)
A July 10-Aug. 10, 2006 inspection of the prescription drug manufacturer found significant deviations from the GMP regulations which included the following: Significant deficiencies in the company . . .

Wheaton Franciscan Healthcare, Waterloo, IA, Jan. 24 (Rockville, MD).(BIOLOGICS)
A Sept. 13-15, 2006, BioResearch Monitoring inspection of the facility's IRB was conducted to determine whether its procedures for protecting human subjects complied with applicable FDA regulations. . . .

Power Products, Kansas City, MO, Jan. 16 (Rockville, MD).(MEDICAL DEVICES)
The marketer of the Sleep Right Adjustable Night Guard was determined by FDA to be marketing the medical device without approval, in violation of the FD&C Act. FDA reviewed its records and found t . . .

Mathias Fobi, M.D., Hawaiian Gardens, CA, Jan. 24 (Los Angeles).(MEDICAL DEVICES)
The clinical investigator was inspected Sept. 19-29, 2006, and it was found that he had failed to adhere to several regulations, including informed consent requirements, obtaining FDA and IRB approv . . .

Levitronix, Waltham, MA, Jan. 19 (Rockville, MD).(MEDICAL DEVICES)
A Sept. 26-29, 2006, inspection determined that the manufacturer of the Levitronix CentriMag Extracorporeal Blood Pumping System and the Levitronix CentriMag Back Up Console was in violation of GMPs . . .

Hardy Diagnostics, Santa Maria, CA, Jan. 8 (Rockville, MD).(MEDICAL DEVICES)
FDA determined during a recent voluntary recall of one of the firm's products that it was marketing the HardyCHROM 0157 in the U.S. without marketing clearance or approval, in violation of the FD&C . . .

Encore Medical, Austin, TX, Jan. 11 (Dallas, TX).(MEDICAL DEVICES)
FDA stated that an inspection of the manufacturer of orthopedic products for reconstructive surgery of hips, knees, shoulders, and spines found GMP violations that included but were not limited to t . . .

DreamWest Innovations, San Antonio, TX, Jan. 19 (Dallas, TX).(MEDICAL DEVICES)
A Nov. 1-9, 2006 inspection of the specification developer and manufacturer of the SwiftGrip Rapid Intubation Kit, found that the firm was not in full compliance with the GMPs of the Quality System . . .

Charles O'Shaughnessy, M.D., Elyria, OH, Jan. 8 (Cincinnati, OH).(MEDICAL DEVICES)
An Oct. 26-Nov. 9, 2006, FDA inspection of the clinical investigator found that his coronary stent clinical trial was not conducted in accordance with the signed agreement with the sponsor, the inve . . .

Omnicare/Heartland Repack Services LLC, Covington, KY, Jan. 11 (Cincinnati, OH).
An inspection of the firm's drug repackaging facility, Heardand Repak Services LLC, Toledo, OH, conducted June 27-Aug. 11, 2006, revealed numerous GMP violations in the area of quality control syste . . .

Daiichi Sankyo, Parsippany, NJ, Jan. 5 (Rockville, MD).
FDA reviewed a wall calendar and dry erase board that advertised Evoxac capsules (cevimeline hydrochloride), and found that these promotional materials were false or mis-leading because they present . . .

Bell-More Laboratories, Hampstead, MD, Jan. 5 (Baltimore, MD).
An Aug. 7-17, 2006, GMP inspection of the drug testing laboratory found what FDA stated to be "severe" violations of GMP regulations. The violations included but were not limited to: failure to es . . .

INCELL Corp., San Antonio, TX, Dec. 6, 2006 (CBER).(BIOLOGICS)
An inspection conducted Sept. 19, 2006, conducted as part of FDA's Bioresearch Monitoring Program to evaluate INCELL's adherence to GLP regulations found several violations. Specifically, INCELL f . . .

VIASYS Healthcare, Conshohocken, PA, Dec. 12, 2006 (Cincinnati).(MEDICAL DEVICES)
An Oct. 17-Nov. 3, 2006, inspection of the manufacturer of the continuous, positive air pressure devices found that the firm failed to establish a complaint handling system that assured all complain . . .

TMJ Implants, Golden, CO, Dec. 20, 2006 (CDRH).(MEDICAL DEVICES)
FDA reviewed the firm's website on Sept. 5, 2006 and noted that the medical device firm is promoting hemi and full mandibles without premarket clearance or approval from FDA. According to the site . . .

Robert Ritch, M.D., New York, Dec. 4 (CBER).(MEDICAL DEVICES)
An FDA inspection conducted Sept. 11, 2006, to confirm whether Ritch's clinical investigation complied with applicable federal regulations found a number of violations. The agency stated that the . . .

Quick-Fill Mobile Oxygen, Gulfport, MS, Dec. 8, 2006 (New Orleans).(MEDICAL DEVICES)
The agency's Aug. 14, 15 and 18, 2006 inspection of the firm's compressed oxygen manufacturing facility in Slidell, LA, found what it termed to be significant violations of cur rent GMPs, which incl . . .

Nasiff Associates, Central Square, NY, Dec. 8, 2006 (Jamaica, NY).(MEDICAL DEVICES)
FDA inspected the manufacturer of the Cardio-Card Interpretation System from Oct. 12-18, 2006, and found that the device manufacturer's products were not in conformance with current GMP requirements . . .

MRL, Buffalo Grove, IL, Dec. 6, 2006 (CDRH).(MEDICAL DEVICES)
FDA's May 22 July 20, 2006 inspection of the manufacturer of automatic external defibrillators were not in conformity with the current GMP requirements of the Quality System (QS) regulation. Viola . . .

Lee Laboratories, Ponca City, OK, Dec. 26, 2006 (Dallas).(MEDICAL DEVICES)
The manufacturer of extraoral orthodontic headgear Sept. 25-27, 2006, was not in conformance with the Quality System regulation in the following ways: Management failed to ensure that an adequate . . .

Biotecx Laboratories, Houston TX, Dec. 8, 2006 (Dallas).(MEDICAL DEVICES)
A Sept. 5-8, 11, 22 and 25, 2006 inspection of the manufacturer of Opticoat T3 and T4 EIA (Enzyme Immunoassay) kits found that the firm was in violation of current GMPs of the Quality System regulat . . .