FDA published three drug warning letters this week, one of which was issued in April.
The warning letter to Strides Pharma Science Limited revealed the firm to be shredding GMP documents. Fundamental stuff here.
Also, Indoco Remedies announced that their solid oral dosage form plant in Goa, India received a warning letter based on an inspection in January 2019. FDA should post this soon and we will cover it when it becomes available.
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DRUGS | Ecometics Inc
Ecometics Inc (Norwalk, CT) received a warning letter on April 16, 2019 based on the outcome of an inspection ending August 17, 2018. The firm manufactures OTC and prescription drug products and non-drug products including hair removal cream, insect repellant, and dyes.
The FDA identified GMP violations and also notes that the firm did not fulfill their registration and listing responsibilities and thus the drugs are misbranded. The firm operates as a contract manufacturer. FDA reminds the firm that some of the observations are repeats from a 2016 inspection.
- The firm does not have adequate cleaning processes to prevent cross-contamination between drugs and non-drug products.
- The water system is not adequately designed, controlled, maintained and monitored to ensure that it produced adequate quality water (it appears to be purified water). Basically, the system is not validated.
- The stability program is not adequate to demonstrate that drug products meet specifications through expiry. Methods are not stability indicating for active ingredients. Method validation does not “demonstrate that your stability test methods are reliable, meaningful, and specific for the content of degradation products and other components of interest in a drug product.” This is a repeat observation from a September 2016 inspection.
DRUGS | Strides Pharma Science Limited
Strides Pharma Science Limited (Bangalore, India) received a warning letter on July 1, 2019 based on the outcome of an inspection ending February 5, 2019. There were only two deficiencies identified including but not limited to the following:
- The Quality Unit lacks appropriate responsibility and control over manufacturing operations. Bags of discarded uncontrolled GMP documents, including batch records, were awaiting shredding and disposal. The Quality Unit did not review or check these document prior to disposal.
- Management of OOS events was not thorough or scientifically sound.
- The firm is also asked to address the common boilerplate requirements for data integrity remediation after stating 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.”
CELL AND GENE THERAPY | Virginia Center for Reproductive Medicine
Virginia Center for Reproductive Medicine (Reston, VA) received a warning letter on July 1, 2019 based on the outcome of an inspection ending February 25, 2019.
The warning letter includes a detailed description of where the firm’s responses to the form 483 were inadequate. All deficiencies were associated with issues of communicable diseases and assurance that donors were not at demonstrable risk.
Deficiencies include but are not limited to:
- Donated tissue is not tested for relevant communicable diseases.
- The donor health was not evaluated by review of their medical records including completion of a questionnaire that includes questions which may place the donor at increased risk for communicable diseases.
- A responsible person failed to determine and document the eligibility of donor cells or tissue based on donor screening and testing.
- Failure to determine whether a donor is eligible.
- Failure to provide a summary of records that list and interpret all results of all communicable diseases.
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