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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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, . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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 . . .
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.
. . .
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 . . .
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