Enforcement included only two warning letters this week: we cover one BIMO warning letter and one issued to an OTC drug firm. The OTC firms continue to show that they have a limited grasp of the fundamentals of GMPs required for their product type.
Also, Lupin announced that they received a warning letter this week based on the outcome of an inspection of their Mandideep facility, an API and dosage form site. The extensive and problematic form 483 covered both API and dosage form manufacture. The warning letter should be published on the FDA website next week.
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BIMO | Susan P. King-Harris
Susan P. King-Harris (Farmington Hills, MI) received a warning letter on September 9, 2019 based on the outcome of a BIMO inspection ending May 9, 2019. This is another sponsor-investigator situation (FDA posted a warning letter last week to a sponsor-investigator).
A single deficiency is identified:
- The sponsor-investigator failed to ensure that the studies were conducted according to the investigational plan, particularly with regard to inclusion and exclusion criteria.
- FDA notes that “Your response indicated that your overall noncompliance was due to your lack of experience as a clinical investigator and your lack of exposure to the conduct of clinical trials.” Personally, that seems to be a problematic response. Further, “We are unable to undertake an informed evaluation of your written response because you did not specify corrective actions that you have taken, as a sponsor and clinical investigator, to prevent similar violations in the future. We are concerned that most of the corrective actions taken appear to represent the actions of Beaumont Hospital and do not reflect corrective actions that you personally have taken as a sponsor and clinical investigator.”
DRUGS | Deb USA (now SC Johnson Professional, Inc.)
Deb USA, now SC Johnson Professional, Inc. (Stanley, NC), received a warning letter on June 11, 2019 based on the outcome of an inspection ending October 30, 2018. The warning letter was sent to the Chairman and CEO located in Wisconsin. The firm manufactures OTC products.
Along with the GMP violations, they have provided “inaccurate information” in the listing information for the firm. FDA suggests that the firm employ qualified consultants to assist them in correcting their GMP deficiencies. Overall, FDA identified that the firm has an inadequate Quality Unit and has deficiencies in data governance/data integrity.
Deficiencies include but are not limited to:
- The Quality Unit failed to follow the firm’s procedures, particularly in ensuring that drug product batches are released only when satisfactory testing is completed. The firm had been releasing product without reviewing and approving microbiology test results. The Quality Unit also did not initiate investigations into OOS results.
- The firm did not have a procedure governing the management of HPLC data. FDA notes they didn’t require the same number of replicate HPLC injections to average and calculate the final result. And while they committed to implement a written procedure, they did not commit to performing a retrospective review of all chromatographic data from HPLC analysis.
- Laboratory personnel did not follow procedures. FDA noted this in regard to enumeration of viable micro-organisms evaluation. In addition, the testing activities were not recorded at the time they were performed. FDA identified micro test plates in the trash yet there was no record of their receipt, preparation, incubation or reading. Further test result sheets were not completed and the analyst informed the investigator they would do this later, from memory.
- The investigators identified where the firm had overwritten electronic data, discarded original testing records and failed to report OOS results. The HPLCs were configured to permit overwriting of data and thus the original data are not retrievable; torn up HPLC chromatograms were found in a dumpster outside the facility. The firm is asked to provide responses to the typical boilerplate instructions regarding data integrity remediation. FDA states that “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”
- The firm releases drug product without the evaluation and approval of microbiological results. Note that this is also listed in the first deficiency as a failure of the Quality Unit.
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