Abbott Laboratories Abbott Park, IL (3/25). Inspected Lake Forest, IL Hospital Products Division 4/22-5/1/03 and 5/28-9/2/03. QSR deviations, adulterated: Firm failed to revalidate the manufacturing and sterilization process where appropriate in the on 12/19/01 Abbott began using (purged) to manufacture drip chambers for (purged) IV set products, despite the fact that the firm’s specifications required otherwise. Yet it had no documentation of validation of the new process change. Abbott also failed to maintain procedures for implementing corrective and preventive action and did not establish adequate procedures for quality audits, etc. (intravenous administration sets); FDCA 501(h), 21CFR 820.22, 820.75(c), 820.100(a), 820.50, 820.25(b), 820.22 (CHI-5-04)
http://www.fda.gov/foi/warning_letters/g4643d.pdf
Able Laboratories South Plainfield, NJ (4/19). Inspected 1/15-2/4/04. Violations: Company did not submit to FDA 27 adverse drug experience reports it received, including reports for lithium caps, methylphenidate tablets, and carisoprodol. Firm also did not develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of Postmarketing Adverse Drug Experiences to FDA.
http://www.fda.gov/foi/warning_letters/g4651d.pdf
Bescon Co. Chunan-City, Chungham, Korea (4/23). Inspected 11/24-27/03. GMP deviations, adulterated: Firm failed to adequately validate the terminal steam autoclave sterilization process and the foil sealing process. There was also a failure to document acceptance activities to include those performed, the dates the activities were performed, the results, and the signature of the person conducting the activities. Bescon also failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specification, etc. (daily wear soft contact lenses); FDCA 501(h), 21CFR 820.75(a), 820.80(a)(e), 820.70(a) (No Code)
http://www.fda.gov/foi/warning_letters/g4657d.pdf
Computron Display Systems Mt. Prospect, IL (4/14). Inspected 10/14-15/03. QSR deviations, adulterated: Company failed to establish and maintain a quality system that is appropriate for the specific medical devices being manufactured or to establish quality system procedures and instructions for the devices. Computron did not establish procedures to identify training needs and ensure that all personnel are adequately trained in order to perform their responsibilities, etc. (C-arm Fluoroscopic applications); FDCA 501(h), 21CFR 820.50, 820.20(e), 820.20(a)(d), 820.100(a), 820.181, 820.30(a)(i), 820.80(b), 820.22, 820.40, 820.198, 820.160(a), 820.184, 820.25(b) (CHI-7-04)
http://www.fda.gov/foi/warning_letters/g4647d.pdf
Consolidated Chemical St. Louis, MO (3/23). Inspected 11/17-12/2/03. GMP violations, adulterated: No investigation or an incomplete investigation was conducted or documented for two lots of Tech 200 Dental Rinse that failed initial microbiological testing Retests with different samples were performed with passing results and no investigations were conducted. One of the lots in its entirety was distributed. The other lot showed heavy microbiological contamination toward the end of the run. Some cases were rejected and the others were released and distributed. Other drug products failing to meet established specifications were not rejected. Firm is also using municipal water to manufacture pharmaceutical drug products and to clean manufacturing equipment and filling lines, instead of purified water as specified in the USP, etc. (antimicrobial cleansers and OTC topical drug products); FDCA 501(a)(2)(B), 21CFR 211.22, 211.192, 211.165(f), 211.113(a), 211.100(a), 211.115(a), 211.67(a), 211.194(a)(2), 211.166(a)(1), 211.184 (KAN-2004-05)
http://www.fda.gov/foi/warning_letters/g4642d.pdf
Novartis Pharmaceuticals East Hanover, NJ (4/21). Reviewed a professional sales aid for Diovan tablets. False and misleading: Sales aid claims that Diovan is effective in treating patients with Type 2 diabetes and hypertension to preserve renal function, a claim which FDA says is not approved and has not been demonstrated by substantial evidence or clinical experience. The drug has been approved for the treatment of hypertension and heart failure in patients who are intolerant of angiotensin-converting enzyme inhibitors. (Diovan); FDCA 352(a), 21CFR 202.1(e)(6)(i) (No Code)
http://www.fda.gov/foi/warning_letters/g4652d.pdf
Old Hickory Medicine Company Andalusia, AL (4/21). Inspected 11/18-20/03. GMP deviations, adulterated, misbranded: Unapproved new drugs. For example, the label for Old Hickory Ear Drops bears a claim, “for softening and aid of the removal of ear wax and to relieve the minor irritation caused by the wax accumulation.” Therefore the product is subject to the final regulations covering OTC topical otic drug products. The label does not differentiate between active ingredients and inactive ingredients. This causes all ingredients to be active, but none of the listed ingredients is permitted as an active ingredient. Firm also does not perform any finished product testing prior to release of drug products for distribution. Old Hickory has not performed any stability testing to support the three-year expiration date assigned to the finished drug product, etc. (Old Hickory Ear Drops, Foot-O-Latum, Athlete’s Foot & Ringworm Remedy, etc.); FDCA 501(a)(2)(B), 502(c), 502(f)(1)(2), 505(a), 21CFR 344.50, 358.550(a)-(d), 333.250(a)-(d), 358.550(a)-(d), 333.250(a)-(d), 358.550(a)-(d), 210, 211.165(a)(b), 211.166(a)(b), 211.84(d)(1)(2), 211.110(a), 211.22, 211.25(a), 211.67(c), 211.101(b)(d), 211.125(a), 211.122(a), 211.160(b)(4), 211.150 (2004-NOL-24)
http://www.fda.gov/foi/warning_letters/g4653d.pdf
Staar Surgical Monrovia, CA (4/23). Inspected 12/3-11/03. Clinical investigator violations: Sponsor failed to obtain FDA approval prior to initiating the study. It did not obtain continuing IRB review and failed to comply with sponsor responsibilities. (device study); 21CFR 812.20(a)(1), 812.40, 812.42, 812.43(c) (No Code) http://www.fda.gov/foi/warning_letters/g4655d.pdf
Sunder Biomedical Tech Taiwan, Republic of China (4/23). Inspected 11/10-14/03. QSR deviations, adulterated: Company failed to validate with a high degree of assurance a process that cannot be fully verified. Validation for the firm’s Class (purged) assembly clean room is inadequate in that there is no written validation protocol that identifies the specific locations for air and surface sampling areas, the action level, and the environmental conditions of the clean room at the time the samples were taken. Procedures to control the design of the device have not been established, etc. (hemodialysis blood tubing sets and AV Fistula needle sets); FDCA 501(h), 21CFR 820.75(a), 820.30 (No Code)
http://www.fda.gov/foi/warning_letters/g4656d.pdf
Texas Orthopaedic Products & Services Rockwall, TX (4/12). Inspected 11/13-14/03. QSR deviations, adulterated, misbranded: Firm did not establish procedures for management review, internal audit, and complaint handling or for procedures for device assembly and repackaging, acceptance or rejection of finished devices, control of nonconforming products, and device history records. Firm has not established written complaint handling procedures to indicate how complaints are received, investigated, and documented, and has not documented customer complaints, etc. (patient protective restraints, electrodes for a powered muscle stimulator, powered muscle stimulator); FDCA 501(h), 502(o), 502(f)(1), 510(k), 21CFR 820.184, 820.20, 820.198(a), 820.30, 820.80(b), 820.70(a)(1), 820.90(a) (2004-DAL-WL-14)
