Latest FDA Warning Letters
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Banner Pharmacy Services, LLC Phoenix, AZ (5/5). Inspected Chandler, AZ facility 3/16/15-3/2015. Violations, adulterated, misbranded, unapproved new drugs: The investigators noted that the facility is not adequately designed for sterile drug production. Investigators observed the ISO 5 area contained peeling paint and dark yellow residues on the walls. Also, the ISO 5 area is not separated from the ISO 7 area in a way that allows for adequate pressure differentials to be maintained between areas of different air classifications. The facility does not have any FDA-approved applications on file for its drug products. It compounds drug products that are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and therefore adequate directions for use cannot be written so that a layman can use these products safely for their intended use, etc. (compounded drugs); FDCA 501(a)(2)(B), 503(B), 502(f)(1), 501(a)(2)(A)&(B), 505(a), 502(f)(1), 21 CFR 211.42(c)(10)(iii), 211.113(b)), 211.42(c)(10)(i)), 211.42(c)(10)(iv)(v), 211.192, 211.28(a)http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501265.htm
BBT Biotech Gmbh Baesweiler, Germany (5/16). Inspected 5/4-7/15. GMP deviations, adulterated: The firm failed to follow a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. For example, since 1/2012 the firm shipped about (purged) batches of (purged) API to the U.S. for which it has no stability data to support the expiration dates. Also, the firm did not have a change management program. It did not require the quality unit to review or approve changes in suppliers. The response was inadequate because the firm failed to provide any information on the effect of supplier changes on the distributed API, such as the effect of changes on the impurity profile or the stability of the API, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502347.htm
Beauty & Health International, Inc. Garden Grove, CA (2/5). Inspected 8/25/15-8/28/15 and reviewed Web site at www.nutriwell.net. GMP deviations, adulterated, misbranded, unapproved new drug: The claims on the firm’s product labels and its Web site establish that the products are drugs. For example, the product label for Dr. Immune H-100 claims: “Improve recovery from extreme stress and illness like burn, surgery, and cancer,” etc. (Nopal with garlic, Tea Tree Oil, Shea Butter Oil, Ginseng Gro Oil, Eye Wrinkle Cream, Quinol); FDCA 502(f)(1), 505(a), 402(g)(1), 403(q)(1)(A), 21 CFR 111.70, 111.75, 111.103, 111.65, 111.210, 111.210(f), 11.210(h)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502275.htm
David Bridgewater Farm Bowling Green, KY (5/16). Inspected 12/1-3/15. Adulterated: FDA found that the farm adulterated a new animal drug in that it did not use Baytril 100 (enrofloxacin, NADA 141-068) as directed by its approved labeling or by the servicing veterinarian’s prescription. The investigation found that the farm administered Baytril 100 to a calf, identified with back tag (purged) without following the withdrawal period and animal class as stated in the approved labeling. This extralabel use of Baytril 100 was not under the supervision of a licensed veterinarian and resulted in an illegal drug residue. Baytril 100 is prohibited for extralabel use in calves to be processed for veal, etc. (veterinary drug Baytril); FDCA 501(a)(5), 21 CFR 530.11(a)&(c), 522.812(e)(2)(iii), 530.41(a)(10), 512
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm502320.htm
Qiagen Hilden, Germany (5/16). Inspected Germantown, MD firm 1/19-2/5. QSR deviations, adulterated: Procedures for corrective and preventive actions (CAPA) were not adequately established to ensure that CAPAs are effective. For example, CAPA 2014-14 was opened due to endotoxin contamination being found in two lots of Nil blood collection tubes, which could lead to potentially false negative results. This CAPA was not effective because portions from both lots were released despite multiple failures being obtained during lot release testing. The firm’s contract manufacturer did not have process validation for the several destructive final release tests for the QuantiFERON blood collection tubes. Design changes were not opened for changes in design outputs for the TB Antigen and Nil blood collection tubes, etc. (QuantiFERON-TB Gold test device); FDCA 501 (h), 502(t)(2), 21 CFR 820.100(a), 820.30(i), 820.30(d), 820.198(c), 820.250(b), 803.50(a)(2), 803.17, 806.10
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501292.htm
Renovis Surgical Technologies, Inc. Redlands, CA (5/5). Inspected 1/26/15-2/13/15. QSR deviations, adulterated: The firm failed to confirm that design output meets design input requirements during design verification. It also failed to have risk analysis. The firm’s response is inadequate, etc. (specification developer and complaint file establishment of medical products, including spinal implant (vertebral body replacement cages), pedicle screw systems, primary hip and knee replacement systems and surgical instrument devices); FDCA 501(h), 21 CFR 820.30(f), 820.30(g)http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501776.htm
Rocky Fork Formulas, Inc. Westerville, OH (5/13). Inspected 5/22,28, 7/8, and 8/27/15. Reviewed Web site at https://www.rockyforkformulas.com in March. GMP violations, adulterated dietary supplements, unapproved new drugs, misbranded: The claims on the site establish that the products are drugs. For example, the Web site makes a claim for EPA 1000: “These oils have been cited in numerous studies as being an important factor in preventing heart and coronary disease.” The firm failed to establish specifications that provide sufficient assurance that the products it receives from a supplier for packaging or labeling as dietary supplements (and for distribution rather than for return to the supplier) are adequately identified and are consistent with its purchase orders, etc. (Angio Fin, Arthritis Complex HS, EPA 1000, Gluco-Poise, Liver Complex, Niacin 500 Time-Released, Prostate Complex HS, Univase, Virex Complex); FDCA 502(f)(1), 403(i)(2), 403(q)(1)(A), 403(q)(5)(F), 403(r)(6)(C), 403(q)(5)(F), 403(s)(2)(B), 403(y), 21 CFR 111.70(f), 111.165(b)&(c), 111.403, 111.553, 111.503, 111.83(a)&(b), 101.36(b)(2)(i)(B), 101.36 (b)(2)(i)(iii)&(d)&(e)(6)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501556.htm
Somnowell, Inc. Bellevue, TN (5/12). Inspected 2/11-3/10. QSR deviations, adulterated: Procedures for quality audits have not been established and the firm has not conducted any quality audits. It has not established procedures for evaluating suppliers, contractors, consultants, and purchasing data. Also, the firm has not established a design history file for its “Somnowell” device, which is a Class II medical device used for treating snoring and sleep apnea, etc. (anti-snoring/sleep apnea device); FDCA 501(h), 21 CFR 820.22, 820.20(c), 820.50, 820.30, 820.30(i), 820.100(a), 820.198(a), 820.40
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501557.htm
Tai Heng Industry Co., Ltd. Shanghai, China (5/812). Inspected 5/4-11/15. GMP deviations, adulterated: The investigator found that batch samples were routinely re-tested following failing or atypical results until acceptable results were obtained. Failing or atypical results were not investigated or included in official laboratory control records. During the inspection, an FDA investigator discovered a lack of basic laboratory controls to prevent changes to the firm’s electronically stored data and paper records. It relied on incomplete records to evaluate the quality of its drugs and to determine whether they conformed with established specifications and standards, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501282.htm