Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Anybattery, Inc. Rosemount, MN (4/29). Inspected 10/21-11/17/14. QSR deviations, adulterated: There is no procedure established for analyzing, investigating, and identifying actions needed to correct and prevent recurrence of nonconforming product and other quality problems through the analysis of processes, work operations, quality audit reports, quality records, complaints, and returned product. Also, records of these CAPA inputs are not maintained. The firm also failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. For example, of the 14 returned goods authorization (RGA)/order form records selected for review, several RGAs did not contain a documented reason for return and were not evaluated to determine whether the RGA met the formal definition of a complaint, etc. (replacement batteries for medical devices); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a), 820.30(a), 820.50, 820.80(b)&(d), 820.184, 820.90(a), 820.20(c), 820.22, 820.72(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm445690.htm
CXL-USA, LLC Rockville, MD (4/1). Inspected 8/18-19/14. Clinical investigation sponsor violations: The firm failed to submit an IND for the conduct of clinical investigations with an investigational new drug. It also failed to ensure proper monitoring of the clinical investigations. For example, during the inspection it indicated that CXL-USA (1) did not review investigation-related data or records, (2) did not perform any site monitoring, and (3) relied on clinical site “self-monitoring,” etc. (clinical investigation); 21 CFR 312.2(a), 312.50
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm445817.htm
EMcision Ltd. Liver Surgery Sec., Hammersmith Hospital London, UK (11/20). Inspected 8/11-14/14. QSR deviations, misbranded: The firm failed to develop, maintain and implement written MDR procedures. It also failed to establish and maintain procedures for implementing corrective and preventive action. It failed to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (specifications developer for the Habib EndoHPB); FDCA 502(t)(2), 501(h), 21 CFR 803.17, 803.3, 820.100(a)&(b), 820.198(a), 820.30(i), 820.40
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm446035.htm
Moor Instruments Ltd. Devon, UK (12/18/14). Inspected 8/18-21/14. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for validating the device design. The design change procedure does not include requirements for validation or verification of design changes before their implementation. The firm does not have rework procedures and eight of its nonconformance records were incomplete, in that these records did not document retesting and reevaluation results after rework, to ensure that the product met its current approved specification, etc. (moorVMS-LDF and moorVMS-LDF-HP Laser Doppler Blood Flow Monitor devices); FDCA 501(h), 21 CFR 820.30(g), 820.90(b)(2), 820.70(b), 820.184, 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm446038.htm
Novartis Animal Health, US, Inc. Greensboro NC (5/4). Reviewed promotional materials for Denagard (tiamulin hydrogen fumarate) plus CTC (chlortetracycline hydrochloride), including a sell sheet entitled “Control Disease in Grow-Finish Pigs…” submitted to FDA 8/8/14. Adulterated, misbranded: The promotional materials provide evidence that Denagard plus CTC is intended for new uses for which it lacks approval, conditional approval or an index listing, and for which its labeling does not provide adequate directions for use. According to the FDA-approved product labeling, it is a medicated feed that is approved for the control of swine dysentery associated with Brachyspira (formerly Serpulina or Treponema) hyodysenteriae susceptible to tiamulin, and for treating swine bacterial enteritis caused by Escherichia coli and Salmonella choleraesuis sensitive to chlortetracycline, and treating bacterial pneumonia caused by Pasteurella multocida sensitive to chlortetracycline. The promotional materials make claims of increased weight gain and feed efficiency. FDA says “use of the term ‘broad spectrum control’ implies that this product could be used for control of a wider range of disease organisms than the four pathogens included in the product approval,” etc. (Denagard plus CTC); FDCA 501(a)(5), 502(f)(1)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm446201.htm
