FDA Warning Letters Week of 4/20/2020: PMA, IDE, & Untitled Letter to Stem Cell Firm

No warning letters to drug firms were posted this week.  We do provide one warning letter issued to a device firm, as well as one untitled letter issued to a stem cell firm.

FDA also issued two warning letters to companies selling cannabidiol (CBD) containing products with claims of treating a variety of diseases, including opioid addiction, here and here.  FDA determined these were unapproved new drugs and also misbranded. 

FDA continues issuing warning letters to firms selling products to prevent, diagnose, or treat COVID-19 infections. There is simply too much money to be made to think that the FDA can identify and stop it all. 

The Economic Times of India announced that an FDA inspection of the Aurobindo facility, Unit IV at Hyderabad, conducted November 4-13, 2019, is classified as OAI.  The facility manufactures sterile injectable products.  We should look for the warning letter soon.  Aurobindo sites received five other forms 483 in 2019.  I would not be surprised to see this form 483 posted on the FDA website soon and perhaps a warning letter that addresses multiple sites.

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UNTITLED LETTER | Kimera Labs, Inc.

Douglas Spiel, MD and Duncan Ross Ph.D. of Kimera Labs, Inc (Miramar, FL) received an untitled letter on April 10, 2020, based on the FDA’s review of the firm’s website.  The firm manufactures mesenchymal stem cell exosomes for scientific and clinical research.

FDA cites them for descriptions of their products to treat a variety of diseases and illnesses including Parkinson’s disease, brain injuries, diabetes, stroke, and spinal cord injuries.  FDA notes that such products would be regulated as drugs and biological products.  An untitled letter issued April 1, 2020, to Dynamic Stem Cell Therapy also mentions concerns about exosome products, noting they are regulated as drugs and biologics and require review and approval prior to marketing.  This untitled letter also identifies a recent FDA public Safety Notification on these products.


DEVICE | Tenderneeds Fertility LLC

Tenderneeds Fertility LLC (Greenville, IN) received a warning letter on April 13, 2020, based on the outcome of an inspection ending December 13, 2019.  The firm imports devices and manufactures several kinds of Intrauterine Insemination and Intracervical Insemination kits. 

The kits are deemed adulterated because the firm does not have an approved premarket approval application (PMA) or an approved investigational device exemption (IDE) supporting the conduct of clinical studies.  Most notably, the firm purchased kits intended for use in animal insemination and resold them as device components in their kits intended for use in humans.  The kits are deemed misbranded because they did not notify the FDA of their intent to commercially distribute the products.  Further, they are misbranded because they do not include adequate directions for use, particularly because they are intended for home-use. 

FDA also notes that the firm manufactures anonymous donor semen and is therefore governed by the HCT/P regulations, 21CFR1271, particularly in regard to donor screening and qualification.  The firm has not provided a written response to the form-483inspection observations issued at the close of the inspection.  FDA recommends the firm notify recipients of semen from the donor “…for whom no required testing, required screening, or donor eligibility determination were performed that you failed to complete such testing, screening, or determination prior to providing the semen to the recipients.

In the warning letter, the FDA “requests” their attendance at a regulatory meeting scheduled for May 5, 2020.  It is generally never a good sign when the FDA invites you to a regulatory meeting.  

Deficiencies include but aren’t limited to failure to comply with the QSR requirements in 21CFR 820:

  • The firm’s products distributed between Nov 10 and Dec 10, 2019, were not developed under any design controls.
  • The firm has no design history file for any product.
  • The firm does not have a process for receiving and managing customer complaints.
  • The firm does not have procedures that govern material controls, specifically mentioned in the purchase of devices.  
  • The firm does not have a process or procedures to control product that does not conform to specifications. 
  • The firm does not have CAPA procedures. 
  • The firm does not have procedure(s) that govern Medical Device Reporting (MDR). 

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