GMP audits in India nearly double in FY '07, but inspections
in China drop, CDER chief notes.(Inspections)
BETHESDA, MD -- The trend is toward increased GMP inspections in
India, with 62 occurring in FY 2007, compared to 34 in FY '06 and
33 in FY'05, FDA officials told the annual Generic . . .
GMP audit imminent after 6-year inspection gap, states 2007
risk-based model: Gardner.(Inspections)
WASHINGTON -- As the agency transitions more to risk based models
to increase regulatory scrutiny depending upon public health risk,
FDA's most recent GMP inspection model determines that after . . .
7 CMC guidance documents withdrawn for non-conformity with
FDA's GMP initiative.(CMC)
WASHINGTON -- FDA is withdrawing seven guidance documents for
chemistry, manufacturing and controls (CMC), which were drafted before
the 2001 Pharmaceutical GMPs for the 21st Century Initiative . . .
CDER inspector says firms must manufacture non-pencillin
beta-lactam drugs in separate facility.(APIs/sterile drugs)
ARLINGTON, VA -- GMP regulations specifically require the
separation of penicillin production, and FDA expects non-penicillin
betalactam drugs to be produced in separate manufacturing . . .
Rymed warned for lack of control of process parameters.(Medical
devices)
An Oct. 18-Nov. 8 inspection of Rymed Technologies, Franklin, TN,
the manufacturer and marketer of the Invision-Plus Neutral I.V.
Connector Models and catheter extension sets, found the products . . .
Design and development plan flaws net warning for Newport
Medical.(Medical devices)
Newport Medical Instruments, Costa Mesa, CA, a manufacturer of
ventilators, was determined to be not in compliance with GMP/QS
regulations.
First, the Feb. 21 warning letter stated, the firm . . .
Surgical drape maker cited for CAPAs validated process
procedures.(Medical devices)
A manufacturer of surgical drapes--Medical Concepts Development,
Woodbury, MN--was inspected Oct. 25-Nov. 8, and was determined to not be
in line with current GMPs, FDA said in a warning letter.
. . .
Failing to validate design nets warning for GE
Healthcare.(Medical devices)
GE Healthcare Technologies, Waukesha, WI, was found to not be in
full conformance with current GMP requirements of the Quality Systems
regulation. The firm was cited in the Feb. 22 letter for . . .
Fisher & Paykel written up for quality problems.(Medical
devices)
An Oct. 25-Dec. 6, 2006 inspection found that Fisher & Paykel
Healthcare, Irvine, CA, an assembler of radiant infant warmers and
neo-natal accessory products, was not in conformance with current . . .
Edwards Life Sciences warned for quality data and CAPAs.(Medical
devices)
An April 5-Aug. 10, 2006, inspection determined that Edwards Life
Sciences, Irvine CA, was not in conformance with GMP/Quality Systems
(QS) requirements for medical devices. Some of the deviations . . .
Niagara warned for potential eyewash contamination
problems.(Human drugs)
Niagara Pharmaceuticals, Flamborough, Ontario, Canada, a
manufacturer of an eyewash solution that contains purified water, was
determined to have deviated from GMPs regarding the manufacture . . .
Actavis Totowa nets warning for QC, cleaning validation.(Human
drugs)
A July 10-Aug. 10, 2006 inspection of Actavis Totowa, Little Falls,
NJ, a prescription drug manufacturer, found significant deviations from
GMP regulations which included the following:
. . .
MicroSurgical Tech slapped with 483 for quality system,
corrective/preventive actions.(Medical devices)
A six-item 483 went to MicroSurgical Technologies, Redmond, WA,
because quality data was not appropriately analyzed, and CAPA procedures
were not adequate. The audit was conducted from the Bothell, . . .
Validation process procedures nets 11-item 483 for Electrode
Store.(Medical devices)
The Electrode Store, a medical device manufacturer in Buckley, WA,
received an 11-item 483 because procedures were not implemented for
monitoring and control of process parameters for validated . . .
Cleaning validation, stability SOP trip up API
manufacturer.(Human drugs)
Industriale Chimica, Sacronno, Italy, received a two-item 483 for
incomplete cleaning validation in the manufacture of active
pharmaceutical ingredients (APIs).
The EIR stated that investigator . . .
Pre-approval audit nets 483 for aseptic filling room
criteria.(Human drugs)
Hollister-Stier Laboratories, Spokane, WA, was slapped with a
10-item 483 in a GMP pre-approval inspection for not establishing
criteria for investigating unexplained discrepancies in one of . . .
Hi-Tech written up for OOS and process validation in 10-item
483.(Human drugs)
Hi-Tech Pharmacal, Amityville, NY, received a 10-item 483 for
several out-of-specification (OOS) results at the firm's contract
laboratory, as well as for process validation flaws.
FDA . . .
Pfizer touts risk/science approaches to meeting 'Continuous
Quality Verification'.(Verification/validation)
ATHENS, GA -- When making a decision regarding Continuous Quality
Verification (CQV), industry should always use science and risk-based
approaches to process validation, a Pfizer validation . . .
80% of Inspectorate audits focus on drug quality issues:
Thorsky.(Inspections)
ATHENS, GA -- About 80% of audits conducted by FDA's
five-year-old Pharmaceutical Inspectorate Program concern drug GMPs, the
leader of FDA's Field Drug Committee told a University of . . .
Global GMP requirements pose difficulties for
manufacturers.(International)
ATHENS, GA -- Global GMP regulations, guidelines and policy
documents are increasing and advancing, but FDA regulators and its EU
(European Union) counterparts are concerned that companies are not . . .
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