the glia saga also
"AUTOMATIC DETENTION OF DEVICES THAT HAVE NOT MET DEVICE
GMP'S", Attachment 10/01/99
SUBJECT : AUTOMATIC DETENTION OF DEVICES THAT HAVE NOT MET DEVICE GMP'S
TYPE OF
ALERT : Automatic Detention
PRODUCT : All devices manufactured by manufacturers/shippers as listed in
the Attachment.
PRODUCT CODE: Multiple
HARMONIZED
CODE : Multiple
PROBLEM : Good Manufacturing Practices deviations (DVVG)
PAC FOR
COLLECTION : 82008
COUNTRY : See Attachment
MANUFACTURER
OR SHIPPER : See Attachment
I.D.# : N/A
IMPORTER'S
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission pursuant to
Section 801(a)(1) in that the methods used in, and the facilities
or controls used for, the manufacture of the device do not
conform to the requirements of Section 520(f) [Adulteration,
Section 501(h)]."
RECOMMENDING
OFFICE : CDRH, Office of Compliance, HFZ-323
REASON FOR
ALERT : Foreign inspections of device manufacturers continue to be
conducted. FDA will not allow entry of affected products if
inspection reveals the manufacturer is not currently operating in
accordance with the device Good Manufacturing Practices (GMP's).
When inspection reveals that corrections have been made, the
respective firm's devices will be removed from Automatic
Detention.
INSTRUCTIONS: Automatically detain devices for human use from th
e firms listed
in the attachment.
PRIORITIZATION
GUIDANCE : N/A
FOI : No purging is required.
KEYWORDS : Device GMPs, Good Manufacturing, human use devices, GMPs.
PREPARED BY : Linda A. Wisniowski, DIOP, 301-443-6553.
ATTACHMENT TO IA #89-04 Revised 10/01/99
AUTOMATIC DETENTION LIST...
Listing includes:
...NETHERLANDS
European Medical Contract Manufacturer Adcon-L
Middenkampeweg 17 89MLQ
6545 CH Nijmegen, The Netherlands 9/22/99
FEI# 1000370374 |
