Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Coastal Meds, LLC Biloxi, MS (6/22). Inspected 9/15-23/15. CGMP deviations, adulterated, misbranded, unapproved new drug products: The FDA investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. For example, during aseptic processing, the investigator observed personnel reaching over filled pre-stoppered vials to fill other vials behind the filled pre-stoppered vials, and the sleeve of the non-sterile gown was observed touching the top of filled pre-stoppered vials. Also, operators were producing sterile drug products in the ISO 5 areas with exposed facial skin and facial hair. The facility failed to submit a report to FDA, upon initial registration as an outsourcing facility in 12/2014, and again in 6/2015 identifying the drug products compounded during the previous six month period, etc. FDCA 501(a)(2)(A) and (B), 502(f)(1), 505(a), 301(ccc)(3), 21 CFR 211.42(c)(10)(iv), 211.28(a), 211.113(b), 211.42(c)(10)(v), 211.166(a), 211.192
Chongqing Lummy Pharmaceutical Co., Ltd. Chongqing, China (6/21). Inspected 3/14-16. GMP deviations, adulterated: FDA’s investigator discovered a lack of basic laboratory controls to prevent changes to and deletions from the firm’s electronically-stored data. It relied on incomplete and falsified records to evaluate the quality of its drugs and to determine whether the drugs conformed with established specifications and standards. The investigator’s review of the audit trail for residual solvent stability testing indicated that an analyst manipulated the firm’s computerized gas chromatography system to falsify residual solvent stability results for multiple batches of (purged) API distributed to the U.S. For example, on 3/4, the firm’s analyst set the GC personal computer clock back to make it appear as if testing had been done seven months earlier – on 8/3/15, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)
Eolane Vailhauques Vailhauques, France (2/4). Inspected 9/18/15. QSR deviations, adulterated: The firm’s CAPA procedure, "Actions Correctives et Preventives," dated 12/19/12 does not include requirements for verifying or validating the corrective and preventive action to ensure that such action does not adversely affect the finished device, does not include the requirement of implementing and recording changes in methods and procedures needed to correct and prevent quality problems, and does not ensure that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems. The firm also failed to adequately validate computer software for its intended use according to an established protocol, etc. (galvanic skin response measurement device); FDCA 501(h), 21 CFR 820.75, 820.100(a), 820.70(i), 820.184
General Medical Company Pasadena, CA (6/2). Inspected 10/21-30/15. QSR deviations, adulterated: The firm failed to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit to ensure that, among other things, oral complaints are documented upon receipt, and complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA. The firm has not established and maintained corrective and preventive action procedures that include requirements for analyzing sources of quality data, including returned product, to identify existing and potential sources of non-conforming product or other quality problems. The firm’s device history records do not include the dates of manufacture, the quantity manufactured, the quantity released for distribution, the primary identification label and labeling used for each production unit and any unique device identifier, universal product code or other device identification(s) and control number(s) used, etc. (Drionic Hand/Foot Device and the Drionic Armpit Device); FDCA 501(h), 502(o), 502(f)(1), 21 CFR 803, 820.198(b), 820.100(a), 820.181, 820.75(a), 820.75(c), 820.80(a), 820.184, 820.200(a), 820.20(c), 820.22
Jose Giron, MD Orlando, FL (5/19). Inspected 9/1-10/8/15. Clinical investigator violations: The investigator failed to ensure that the investigation was conducted according to the investigational plan. For example, for 13 out of 14 enrolled subjects he failed to send Visit 1 stool samples to the central laboratory for anaerobic culture assessment, as required. FDA says it is unable to undertake an informed evaluation of the written response because the investigator did not provide a corrective action plan that, if properly carried out, would prevent this type of violation in the future. Protocol (purged) requires that subjects take 400 mg (2 tablets) in the morning and 400 mg (2 tablets) in the evening, for a total of 800 mg of (purged) per day. The investigator failed to adhere to these protocol requirements. On 2/28/13 (first dose), Subject 557 was dosed with 600 mg of (purged) (3 tablets) in the morning and the evening, for a total of 1200 mg of per day. FDA says the investigator’s failure to ensure that subjects received the correct doses of the investigational drug raises significant concerns about the reliability of the data from the investigational site, etc. (drug study); 21 CFR 312.60
Shanghai Desano Chemical Pharmaceutical Co., Ltd. Shanghai, China (6/16). Inspected 5/4-7/15. CGMP deviations, adulterated: The firm failed to have laboratory control records that include complete data derived from all tests conducted to ensure compliance with established specifications and standards. The laboratory personnel conducted “unofficial” testing without appropriate documentation, justification, and investigation. The original, unofficial analyses were stored in a separate “Test” folder and were not part of the official quality control records and the FDA inspection found that the firm performed about 8,400 of these unofficial chromatographic analyses between 2012 and 2014. It also failed to investigate and document a number of production deviations, etc. (active pharmaceutical ingredients); FDCA 501(a)(1)&(2)(B)
Spot On Sciences Austin, TX (4/12). Unapproved new device, adulterated, misbranded: FDA communicated with the firm 4/24/14 via teleconference and outlined three options for it to ensure it is in compliance with FDA laws and regulations concerning its blood collection devices, which are: submit a 510(k) for the devices, label the devices as research use only or label the devices for investigational use only. The firm states on its Web site, www.spotonsciences.com and in correspondence provided to FDA/CDRH/OIR on 4/25/14 that the HemaSpot collection devices are intended for research use only, not for use in diagnostic procedures, but the Web site has a press release dated 3/10/14, which has information that it has partnered with CoreMedica laboratories to provide direct-to-consumer diagnostic testing for various medical conditions using the HemaSpot blood collection devices. Also statements on the Web site indicate that the dried blood spot collection devices are intended to be used in diagnostic testing, etc. (dried blood spot collection devices); FDCA 501(f)(1)(B), 502(o), 510(k)