FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products

Lots of warning letters this week issued by the Center for Tobacco Products, including 22 to firms selling flavored, cartridge-based electronic cigarettes.  FDA also posted one issued to a drug manufacturer and one to a clinical investigator.  We cover the latter two below.  And, the Cipla warning letter we referenced last week has not been posted yet.


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BIMO | James R Corbett MD

James R Corbett MD received a warning letter on February 27, 2020 based on the outcome of an inspection ending July 8, 2019 for which Dr. Corbett was a sponsor-investigator.  This was a BIMO inspection.  The investigator missed fundamental requirements for those who conduct clinical trials.

Deficiencies include but are not limited to:

  • The investigator failed to maintain an active IND.  FDA terminated the IND after they didn’t receive an annual report for two years.  Even after the notification that they were to resubmit an IND if they wanted to continue the clinical studies, Dr. Corbett failed to do so and continued to enroll patients.
  • The investigator did not report all changes to the IRB.  Again, this focuses on the letter from FDA terminating the IND.  This action was not reported to the IRB.
  • Clinical subjects who did not meet the enrollment criteria were not excluded from the study.  FDA notes: “We acknowledge that your July 26, 2019, written response indicated that you will discontinue conduct of all FDA-regulated research as either a sponsor or clinical investigator, effective immediately.  However, your response is inadequate because you failed to explain how you would conduct clinical investigations if you should undertake research in the future.” 

DRUGS | Guangzhou Tinci Materials Technology Co., Ltd.

Guangzhou Tinci Materials Technology Co., Ltd. (China) received a warning letter on January 23, 2020 based on the outcome of an inspection ending August 2, 2019.  The firm manufactures APIs and then mixes APIs into a [redacted] which FDA deems to be an in-process material for drug product manufacturing.  Thus, it is subject to 21 CFR 211.  The firm manufactures OTC products though it’s not clear that these are the only drug products they manufacture.   The firm was placed on import alert on November 27, 2019.  FDA also recommends the firm hire qualified consultants to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The first deficiency is well redacted but the mention of “dead legs” and “biofilm” lead me to conclude FDA is talking about the water system, probably purified water, which has inadequate design and maintenance and inadequate monitoring.  The inadequate monitoring focused on microbiological attributes.  This water was used in the manufacture of drug products.  There appears to have been limited, if any, testing for microbiological attributes and the one result for TAMC was 255 cfu/mL.
  • The firm released drug product without testing for microbiological attributes including objectionable organisms.  
  • The Quality Unit is inadequate and didn’t have adequate procedures to govern their activities including lack of SOPs for review of test data, review of raw electronic data, review of batch records prior to approval, and release of product to distribution.  Batches were released with open deviations that were not investigated or reviewed by the QU prior to release.  The firm’s response to the form 483 was not adequate because they did not explain why they distributed lots with the open deviations, nor did they address the need for improvements in the lot disposition process.  FDA notes: “Multiple deviations noted in your manufacturing process cause concern about the quality of your drug product.  It is essential that executive management supports and implements effective actions to address the source(s) of the variations and ensure a continued state of control.”

 

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