HDC Corporation Milpitas, CA (9/17). Inspected 4/14-5/1/03. QSR deviations, adulterated: Firm did not ensure that written procedures are being followed in validating its device designs. Company also failed to perform design validation under defined operating conditions on initial production units, lots or batches, or their equivalents. HDC failed to identify the actions needed to correct and prevent recurrence of nonconforming product and other quality problems. HDC also failed or refused to furnish information required by the Medical Device Reporting regulations, etc. (V-Cath Peripherally Inserted Central Catheter); FDCA 501(h), 502(t)(2), 21CFR 820.20, 820.30(i), 820.40(a), 820.30(g), 820.100(a)(3), 803.50(a) (2925153)
http://www.fda.gov/foi/warning_letters/g4301d.pdf
Oak Lawn Institutional Review Board Oak Lawn, IL (9/17). Inspected 5/5-23/03. Deviations: IRB failed to provide adequate initial review of investigational studies. It also did not provide adequate continuing review of approved studies and did not maintain adequate documentation of IRB procedures, etc. (device study); 21CFR 56.109(a)(b), 56.109(f). 56.115(a)(6) (No Code)
http://www.fda.gov/foi/warning_letters/g4304d.pdf
Premier Dairy Service Argyle, NY (8/29). Inspected 6/17-6/23/03. GMP deviations, adulterated: The master production and control record, reconstitution form, used for reconstituted 1% iodine teat sanitizer batches does not include an appropriate specification for percent iodine. Premier Dairy also failed to test incoming iodine teat sanitizer concentrate to verify identity. The reconstituted iodine teat sanitizer was not labeled with an expiration date, etc. (iodine teat sanitizers for cows); FDCA 501(a)(2)(B), 211.100(a), 211.186(b)(9), 211.160(b), 211.165, 211.84(d)(1), 211.137, 211.194, 211.125 (NYK-2003-33)
