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Pastimes : son of T/FIF -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (221)	10/5/1999 4:26:00 PM
From: dalroi	Read Replies (1) \| Respond to of 673

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