Today FDA released its latest batch of Warning Letters They can be accessed by clicking on the link following each letter.
Animas Corp. West Chester, PA (12/27/11). Misbranded: The firm failed to report to FDA no later than 30 calendar days after the day that it received or otherwise became aware of information that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury. The firm also failed to develop, maintain and implement written MDR procedures. It failed to identify the action needed to correct and prevent recurrence of nonconforming product and other quality problems, etc. FDCA 501(h), 21 CFR 820.100(b), 820.20(c), 803.50(a)(1), 803.17 (12-PHI-04)
Encompass Group, LLC McDonough, GA (12/27/11). Inspected the firm, Albahealth, LLC, 425 North Gateway Boulevard, Rockwood, TN 8/8-10/11. QSR deviations, adulterated, misbranded: The design files for the PulSTAR System did not include documentation the device had ever been validated before production and marketing. When requested, the firm was unable to provide documentation validation had been performed. The firm changed materials for the PulSTAR System during 2/2010 without updating the specifications and documenting material strength testing, etc. (PulSTAR Anti-Embolism Wrap System); FDCA 501(h), 502(t)(2), 21 CFR 820.30(g), 820.30(i), 820.30(c), 803, 806.10(b) (2012-NOL-07)
Herbal Extracts Plus, LLC Bensalem, PA (1/3). Reviewed Web site at www.herbalextractsplus.com in 11/2011 and determined that the products are promoted for conditions that cause them to be drugs. (Cholesterol Reduction Support, Support for High Blood Pressure, and Kidney and Bladder Support); FDCA 505(a), 502(f)(1) (12-PHI-05)
Midmark Corp. Versailles, OH (12/28). Inspected 8/23-9/12/11. QSR deviations, adulterated, misbranded: The firm did not establish adequate procedures to ensure all sources of quality data were analyzed to identify existing and potential causes of nonconforming product or other quality problems. Not all nonconformances were included in the database and analyzed. The firm did not analyze complaints of devices that failed after the warranty period of one year. The firm’s procedure 5.5, “Control of Nonconforming Product Rev. 4,” did not describe what should be done if a finished device was found to be nonconforming. It was also used for rework, but did not include requirements for recording all rework activities in the Device History Record, etc. (steam sterilizers); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.90(a), 820.70(a), 820.80(d), 820.200(a), 820.50(a)(2)&(3), 820.180(b), 820.50(a)(2), 803.17 (CIN-12-234874-08)
New Life Generation, Inc. Indianapolis, IN (10/17). Inspected 7/19-8/10/11. HCT/P regulation deviations: The firm failed to maintain records concurrently with the performance of each step required in subpart C and subpart D of Part 1271. The firm also failed to screen a donor of cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases. For example, the medical history interview record for a donor indicated that the donor had a recent history of drug and alcohol use and had methadone in his/her system at the time of death. The names of two primary care physicians were also documented in the donor’s record, but the physicians were not contacted to request the donor’s records. During the medical history interviews with the next of kin, the screeners were not asking all required questions about a donor’s medical history and relevant social behavior related to relevant communicable disease risk, etc. (human cells, tissues, and cellular and tissue-based products); 21 CFR 1271.270(a), 1271.75(a), 1271.290(e), 1271.160 (2012-DET –03)