FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

20/20 Institute, Indianapolis Lasik Indianapolis, IN (12/18/12). The firm’s promotion of the WaveLight Allegretto Wave Eye-Q Laser misbrands the device. Its Web site fails to reveal material facts, including relevant risk information associated with the use of the WaveLight Allegretto Wave Eye-Q Laser. (excimer laser); FDCA 502(a), 502(q)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333453.htm

AloeScience Labs, Inc. Garland, TX (11/14/12). Inspected 2/27-3/9/12. GMP violations, adulterated: The firm was not able to provide any records to show that you established product specifications for the identity, purity, strength, and composition of the finished batch of (purged). It also provided no documentation of testing or examination results to verify the identities of any dietary ingredients used in the manufacture of the several finished batches of dietary supplements, etc. (dietary supplements); 21 CFR 111.95(b)(1), 111.75(a)(1)(i), 111.260(l)(3), 111.123(a)(8), 111.120(e), 111.205(b)(1), 111.210, 111.255(b), 111.260, 111.155(c).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm332705.htm

DMX-Works, Inc. Palm Harbor, FL (10/26/12). Inspected 6/4-7/12. QSR deviations, adulterated: The firm failed to maintain an adequate Device Master Record. Production procedures and specification drawings were not updated and verified and/or validated as appropriate, for the required performance standard changes to the Image Intensifier and Collimator and the addition of cumulative air kerma and AKR display on equipment manufactured on or after 6/10/06, etc. (Digital Motion X-ray fluoroscopic systems); FDCA 501(h), 21 CFR 820.181, 820.80(e), 820.70(b), 820.50(a), 820.22, 820.184, 820.200(b), 820.80(c), 820.198(a)(1), 1020.30(h)(6), 1002.11, 1002.13, 1010.3(a), 1020.30(j), 1020.30 (d)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333077.htm

Energist Limited Swansea, UK (12/4). Inspected 5/21-24/12. Adulterated, misbranded: The firm failed to adequately develop, maintain and implement written MDR procedures. It also failed to establish procedures for identifying training needs and ensure all personnel are trained adequately to perform their assigned responsibilities. It failed to establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of 21 CFR 820, etc. (Ultra Plus Variable Pulsed Light (VPL), iPulse i150, i200, and i300 Pulsed Light Systems, and a nozzle for the Portrait Plasma System); FDCA 502(t)(2), 501(f)(1)(B), 502(o), 21 CFR 803.17, 820.70(i), 820.30(g), 820.184, 820.181, 820.25(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333299.htm

Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou, China (12/12). Inspected 7/23-26/12. QSR deviations, misbranded: The firm failed to adequately develop, maintain and implement written MDR procedures. A revised version of its MDR procedure submitted at the close of the inspection is inadequate in that it does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. It also fails to establish internal systems that provide for timely transmission of complete medical device reports or that not provide for a standardized review process to determine when an event meets the criteria for reporting under this part. The firm failed to establish and maintain procedures for validating the device design implementing corrective and preventive action, etc. (tracheal tubes, tracheotomy tubes, oxygen masks and cannulas, aerosol masks, anesthetic and ventilation breathing systems, suction tubes and pumps, CPR masks, and nebulizers); FDCA 502(t)(2), 21 CFR 803.3, 803.50(b) and 803.20(c)(1), 820.30(g), 820.100(a)(4), 820.184, 820.72(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333274.htm

Meridian Ag Thun Switzerland (11/26). Inspected 6/4-7/12. QSR deviations, adulterated: The firm’s quality representative indicated that it does not have a corrective and preventive action procedure. It also failed to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria. The firm failed to designate an individual to review for adequacy and approve prior to issuance all documents established to meet the requirements of 21 CFR 820, etc. (Green Laser Merilas 532a); FDCA 501(h), 21 CFR 820.100(a), 820.90(a), 820.198, 820.80(d), 820.40(a), 803.17, 803.50(b)(3)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333460.htm

Raca Enterprises, Inc. dba Life Cycle Herbal Products (12/14/12). Inspected 8/7-20/12. GMP violations, adulterated: The firm’s quality control personnel failed to reject the dietary supplement, (purged) Lot (purged) dated 6/19/12, for which laboratory results indicated the product did not conform to established specifications. The laboratory results for this dietary supplement indicated a positive result for E. coli, but the certificate of analysis for this product specifies “negative” for E. coli, and the firm shipped this lot to a customer on or about 6/22/12 with the certificate of analysis stating this lot had negative results for E. coli. The firm also failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that its manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, etc. (dietary supplement); 21 CFR 111.77(a) and 111.123(b)(2), 111.103, 111.113, 111.140(b), 111.75(a)(1), 111.75(a)(2)(ii)(A), 111.205, 111.75(c), 111.255(b), 111.260.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm332982.htm

Rand Eye Institute Deerfield Beach, FL (12/18). The firm’s promotion of the VISX Star S4 Laser misbrands the device. (excimer laser); FDCA 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333295.htm

ScottHyver Visioncare, Inc. Daly City, CA (12/18). The firm’s promotion of the WaveLight Allegretto Wave Eye-Q Laser misbrands the device. (excimer laser); FDCA 502(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333275.htm

Sunbeam Products, Inc. Boca Raton, FL (12/4). Inspected 7/30-8/3/12. QSR deviations, adulterated: The firm stated to the FDA investigator that it uses its Global Product Development Process as the design control procedure for its Class 2 devices, but it does not address requirements for design input, design output, design review, design validation, design transfer, and design history file for each type of device. The firm also failed to establish and maintain procedures for identifying, documenting, validating, or where appropriate verifying, review, and approval of design changes before their implementation, etc. (heating pads); FDCA 502(t)(2), 21 CFR 820.30(a)&(i), 820.100(a)&(b), 820.198(a)&(e), 820.50, 803.50(a)(1)&(2)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333107.htm

TMS International Oldenzaal, Netherlands (12/13). Inspected 9/11-12/12. GMP deviations: The firm did not include all quality data sources of nonconformance in its Corrective and Preventive Action procedure Also, the firm’s procedures describing the control of nonconforming product do not describe how nonconforming product will be identified, segregated, or marked to prevent misuse, nor how the ultimate disposition of the product will be documented, etc. (Mind Media BV Biofeedback Devices); FDCA 501(h), 21 CFR 820.100(a)&(b), 820.90(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333032.htm

Tianjin Hanaco Xingda Medical Co., Ltd. Tianjin, China (12/5/12). Inspected 8/13-16/12. QSR deviations, adulterated: The firm failed to adequately ensure that where the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedures. Its CAPA Control Procedure does not include requirements for addressing implementation of corrective and preventive actions and recording changes in the CAPA files. No calibration records traceable to national or international standards or an independent reproducible standard were available for instruments used for (purged) testing in the Quality Control lab, etc. (IV administration sets); FDCA 501(h), 21 CFR 820.75(a), 820.100(a)(5), 820.198(e), 820.80(d), 820.72(b)(1), 820.80(e).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333202.htm

Woolfson Eye Institute Atlanta, GA (12/18). The firm’s promotion of the WaveLight Allegretto Wave Eye-Q Laser and the VISX Star S4 Laser misbrands the devices. (excimer laser) FDCA 502(a) & (q)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm333437.htm