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

Better Health Systems, Inc. Monument, CO (4/7). Inspected 12/10-12/14. QSR deviations, adulterated, misbranded: No procedures are in place to process, document, and evaluate complaints, or to determine if complaints represent a Medical Device Report. The firm was not able to provide any instructions, standard operating procedures, or other methods designed to define and control the packaging and labeling of the Bio-Soft Oraliner device, etc. (Bio-Soft Oraliner (Self-Cure and Heat-Cure)); FDCA 501(h), 501(f)(1)(B), 502(o), 510, 21 CFR 820.198(a), 803.17, 820.70(a), 820.184, 820.50, 820.80(b), 820.90(a), 820.100, 820.22
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442685.htm

Doro, Inc. Ontario, Canada (3/9). Inspected 11/10-14/14. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action (CAPA). It has not established design control procedures. Also, the firm has no records of nonconforming product or rework activities, etc. (wheeled stretchers); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.30(a), 820.198(a), 820.50, 820.90(a), 820.181, 820.72(a), 803
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442630.htm

Galena Biopharma, Inc. Discovery Bay, CA (4/3). Inspected 11/17-21/14. GMP violations and violations of FDA’s Postmarketing Adverse Drug Experience (PADE) reporting requirements: The firm failed to develop adequate written procedures for the surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences from all sources. It also failed to report each adverse drug experience not reported under 21 CFR 314.80(c)(1)(i) at quarterly intervals, etc. (Abstral (fentanyl) sublingual tablets); FDCA 505(k), 21 CFR 314.80(b)&(c)(2)(i).
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442577.htm

Martech Medical Products, Inc. Harleysville, PA (4/10). Inspected 2/4-12. GMP deviations, adulterated: Corrective and preventive action activities and/or results have not been adequately documented. The complaint management procedure lacks the essential elements required to evaluate and or escalate complaints that may be reportable as adverse events by Martech or its specification developers, etc. (purged); FDCA 501(h), 21 CFR 820.100(b), 820.198(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442207.htm

Medical Components, Inc. Harleysville, PA (4/2). Inspected 1/13-2/12. QSR deviations, adulterated: Corrective and preventive action activities and/or results have not been adequately documented. A process whose results cannot be fully verified by subsequent inspection and test has not been validated according to established procedures, etc. (dialysis catheters); FDCA 501(h), 21 CFR 820.100, 820.75, 820.70
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442206.htm

Quality Electrodynamics, LLC Mayfield Village, OH (4/10). Inspected 2/10-3/9. MRI coils that are returned for repairs are not being evaluated to determine if they meet the definition of a complaint. A search of the repair database for the past two years using the words artefacts/artifacts, burns and heat revealed 10 reports of burns and 28 reports of heat that were not documented, evaluated and/or investigated as complaints. Rework and reevaluation activities performed on the printed circuit boards (components of the MRI coils) during manufacturing using the surface mount technology process are not documented, etc. (head/neck, shoulder, knee, wrist and body coils which are used in conjunction with MRI scanners to obtain diagnostic medical images); 21 CFR 820.100(a), 820.198(a), 820.90(b)(2), 820.50, 820.75(a), 820.70(a), 820.30(g)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442205.htm

Rebel Distributors Corp. Thousand Oaks, CA (3/31). FDA reviewed the firm’s listing information for four products and found it to be inaccurate and that it does not list the correct application number (cimetidine 300 mg tablet, dimetidine 400 mg tablet, digoxin 0.125 mg tablet, and hydrocodone barbiturate and acetaminophen 10mg/ 500 mg tablet); FDCA 510(j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442671.htm

Region Care, Inc. Great Neck, NY (4/8). Inspected 3/4-3/20/14. Adulterated, misbranded: Investigators observed serious deficiencies in the outsourcing facility’s practices for producing sterile drug products. The investigators observed rust within the facility’s hoods where sterile production is performed. Also they found that it failed to demonstrate through appropriate studies that the hoods are able to provide adequate protection of the ISO 5 area in which sterile products are produced. The facility failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed, etc. (sterile drug products); FDCA 502(f)(1), 505, 501(a)(2)(A)&(B), 503B(b)(2), 21 CFR 211.192, 211.28(a), 211.113(b), 211.58, 211.42(c)(10)(iv), 211.167(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442123.htm

RemedyRepack Inc. Indiana, PA (3/31). FDA reviewed the firm’s listing information provided for colchicine tablet and found it to be inaccurate. (colchincine tablet); FDCA 510(j)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442679.htm

Thermedx, LLC Solon, OH (4/8). Inspected 11/19/14-12/11/14. QSR deviations, adulterated: The firm has not taken appropriate corrective actions for identified non-conformities. It has made 21 software upgrades since the release of the system, 17 of which were not evaluated for potential correction and removals. The firm also failed to clearly define the type and extent of control to be exercised over suppliers, etc. (fluid management systems for gynecological and urological use); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.184, 820.75(a), 820.50(a)(2), 820.30(g), 820.30(f)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm442129.htm

Yunnan Hande Bio-Tech. Co. Ltd. Yunnan Province P.R. China (4/6). Inspected 4/14-17/14. GMP deviations, adulterated: The firm failed to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data. The inspection documented that an analyst at the firm failed to perform the IR identity test for all lots of (purged) API, as part of the quality control release. Instead, the analyst altered the file name in the spectrophotometer containing the sample identification information for API lot # (purged) tested on 4/2/14, to support the release of two previously manufactured lots, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm443247.htm