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

Axiobionics Ann Arbor, MI (12/6). Inspected 7/18-25. QSR deviations, adulterated: The firm is promoting and marketing the Wearable Therapy devices without required marketing clearance or approval. Also, it was noted during the inspection that the president and the graphic designer would discuss projects verbally without documenting design plans for the Wearable Therapy garments including the Plexus Arm Sleeve (Upper Extremity BioSleeve) and the Lumbar BioBelt devices. The firm does not have written design change procedures for making changes to Wearable Therapy Garments. Several devices were released without a release signature and date to show that the release of the device was authorized by a designated individual, etc. (electrical stimulation garments sold under the trade name Wearable Therapy); FDCA 501(h), 501(f)(1)(B), 515(a), 502(o), 21 CFR 820.30(b)&(h)&(i), 820.70(a), 820.80(d), 820.40, 820.181, 820.120(d).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm332151.htm

Basic Organics, Inc. Columbus, OH (12/7). Inspected 3/26-4/6. GMP deviations: The operations manager failed to identify any employee(s) to be responsible for the firm’s quality control operations, and stated that there are currently no quality control operations happening at the firm. Also, the firm failed to provide written procedures required by 21 CFR 111.103. The firm’s response is inadequate because it failed to outline the specific steps it will take to establish and follow written procedures for the responsibilities of the quality control operations. The firm bottles, labels, seals, and distributes dietary supplements, but it does not have a master manufacturing record for its products that includes specifications applicable to packaging and labeling, etc. (dietary supplements); 21 CFR 111.12(b), 111.105(h), 111.205(b)(1), 111.70(a)&(d), 111.503, 111.553, 111.83(a)&(b), 111.255(b), 111.453
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331641.htm

Leisure Products, Inc. Kingsport, TN (11/20). Inspected 1/24-25. QSR deviations, adulterated, misbranded: The firm failed to ensure that its sun lamps are in compliance with the Performance Standards. There are no written Corrective and Preventive Action procedures or complaint procedures. In-process and finished device testing is not documented and there are no in-process or finished device acceptance activity procedures. Also, no purchasing control procedures and quality requirements for suppliers were available for review. The firm failed or refused to furnish material or information respecting the device, as required 21 CFR 803 Medical Device Reporting, etc. (sunlamp products); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a), 820.80(a), 820.50, 820.22, 820.86, 1010.2(c), 1040.20, 1002.13, 1002.11, 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331623.htm

Prime Herbs Corp. San Jose, CA (12/10). Inspected 8/7-14. QSR deviations, adulterated, misbranded: The firm failed to have personnel with the necessary training and experience to perform their jobs. The firm’s representatives stated that they were unfamiliar with the term device history record, and had never seen, requested, or generated device history records or any manufacturing records for the Precision TDP Lamp. The firm also failed to establish a designated unit for receiving, reviewing and evaluating complaints by a formally designated unit. In fact, the firm stated during the inspection that it does not have any procedures for reviewing and evaluating complaints and that if it receives a quality complaint, it forwards the message to its supplier in China, etc. (Precision TDP Floor Lamp — Infrared Heating Lamp); FDCA 501(h), 502(o), 502(t)(2), 501(f)(1)(B), 21 CFR 820.25(a), 820.22, 820.30(a), 820.100(a), 820.120, 820.130, 820.50, 820.80(a), 820.90(a), 820.40, 820.181, 820.198(a), 820.160(e), 820.184 http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331630.htm