Puretek Corporation San Fernando, CA (2/10). Inspected 12/2-5/02, 12/12/02. GMP deviations, adulterated: Company failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed. Testing and release procedures for the distribution of drug products do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release. Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit. Accelerated stability studies, combined with basic stability information, used to support tentative expiration dates are not supported with ongoing full shelf studies, etc. (drug products); FDCA 501(a)(2)(B), 21CFR 211.192, 211.165(a), 211.110(c), 211.84(a), 211.160(b), 211.63, 211.160(b), 211.166(a)&(b), 211.84(d)(2), 211.68(a) (W/L 22-03)
http://www.fda.gov/foi/warning_letters/g3833d.pdf
Skaggs, David, Children’s Hospital, Los Angeles, CA (2/14). Inspected 11/5-7/02. IDE violations: Two subjects had their surgery performed before written informed consent was documented for these subjects. Case report forms were not completed in a timely manner for numerous subjects, physical examinations were not completed or were not documented, and required examinations, the CT and Echo, were not performed as required by the protocol, etc. (device study); 21CFR 50.27(a), 812.100, 812.140(a)(3) (No Code)
http://www.fda.gov/foi/warning_letters/g3835d.pdf
Ultracell Medical Technologies North Stonington, CT (2/3). Inspected North Stonington, CT and Mystic, CT facilities 12/17,18,23,31/02. QSR deviations, adulterated: On a number of occasions during the past two years, the firm’s testing of in-process water used during the manufacture of its devices, revealed microbial results well above the firm’s established action levels. The firm switched sources of in-process water 10/00, but revalidation was not performed to determine the effect this change had on the products’ bioburden prior to sterilization, etc. (ophthalmic surgical sponges); FDCA 501(h), 21CFR 820.75(b)&(c), 820.100(b) (NWE-10-03W)
