FDA Warning Letters Week Of 8/23/2020: Sterility Assurance Failures & Adulterated HCT/P Components

Another busy week for FDA continuing to issue warning letters to firms who claim to diagnose or treat COVID-19.  This week there were also several warning letters issued for failure to comply with the food foreign supplier verification program, the most recent Tobacco Control Act, and food production GMPs.

Among the areas we follow, there were two warning letters, one to an HCT/P manufacturer who also received a warning letter in March 2020, and one to a drug manufacturing site in India.  None of those posted were issued to device firms or outsourcing facilities.

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Drug Warning and Untitled Letters

Wintac Limited

Wintac Limited (Somerset, NJ) received a warning letter on August 13, 2020, based on the outcome of an inspection at one of the firm’s sites in India ending February 19, 2020. FDA recommends the firm hire qualified consultants to assist them in coming into GMP compliance. The two well-detailed deficiencies address failures in sterility assurance. The deficiencies include, but are not limited to:

  • Inadequate investigation of contaminated media fill units. The investigation lacked a scientific justification for focus on only part of the run and ruling out other potential causes; no CAPAs were initiated, and the investigation was closed without assessing how other batches of product manufactured on that line may have been compromised. Similar investigation deficiencies were observed when the firm qualified a new filling line in June 2019.
  • The firm did not establish adequate procedures to prevent microbiological contamination of drug products. Examples include inadequate media fills that were not representative of commercial manufacture. Also, inadequate smoke studies did not include simulation of interventions and other related activities.

Banco Vida Corp

Banco Vida Corp (San Juan, Puerto Rico) received a warning letter from CBER on August 12, 2020, based on an inspection ending September 18, 2019. The firm also received a warning letter in March, 2020. The most recent warning letter documents adulteration of their cord blood products and intermediates. Deficiencies identified during the inspection include but are not limited to:

  • Failure to screen donor cells/tissue by reviewing medical records
  • Aseptic manufacturing processes not validated
  • There is no written procedure for gowning
  • Cord blood intermediate processes not validated
  • Cleaning and maintenance of equipment inadequate
  • EM and personnel monitoring not conducted during manufacture

Device Warning and Untitled Letters

No letters were issued this week. 

Letters to Compounding Pharmacies and Outsourcing Facilities

No letters were issued this week. 

BIMO, GCP and GLP Warning and Untitled Letters

No letters were issued this week. 

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