Week of March 31st, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

Enforcement in terms of warning letter posting was busy this week.  Among those issued were four that were sent to homeopathic drug product manufacturers, continuing a focus evident over the past two years (you can find the FDA press release here).  Lachman Consultants released their perspective last week.  In addition, there were another two to drug product manufacturers and one to an in vitro diagnostics firm.


DRUGS | B. Jain Pharmaceuticals Pvt. Ltd

B. Jain Pharmaceuticals Pvt. Ltd (India) received a warning letter on March 21, 2019 based on the outcome of an inspection ending August 29, 2018.  The firm manufactures homeopathic drug products. The firm was placed on import alert 66-40 on January 9, 2019.  Further, they suggest the firm employ a qualified consultant(s) to come into GMP compliance.  The warning letter also cited that at least some of the homeopathic drugs are misbranded.

Deficiencies include:

  • Facilities are not maintained adequately.  Flies and insects were observed in the room where materials are dispensed and a moth was observed floating in the raw material.  The ceilings in the quarantine room appeared to be stained with mold. Leaking containers were observed in close proximity to others.
  • The firm failed to maintain clean, sanitized or sterilized utensils.  The holding tank on the roof of the facility (probably for water, but the specifics are redacted) was cracked and exposed to the outside environment.  The investigator asked for the microbiological data for 2018 but the firm was unable to provide it, thus there is no way to ensure the system remained in a validated state.
  • The firm did not have a quality unit that provided adequate oversight of manufacturing based on the inadequate facility and the failure to ensure that manufacturing areas were cleaned and sanitized.

 

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DRUGS | Tec Laboratories Inc

Tec Laboratories Inc (Albany, OR) received a warning letter on March 20, 2019 based on the outcome of an inspection ending July 13, 2018.  The firm manufactures over-the-counter (OTC) and homeopathic drug products.  The warning letter also addresses that the firm distributed unapproved new drugs.

Deficiencies include but are not limited to:

  • Products for use on children and on broken/scraped skin were not tested for objectionable organisms prior to release.
  • The firm failed to investigate an Out of Limit result for purified water.  Nor did the firm evaluate the impact that this result could have had on product produced using this water.

DRUGS | Red Mountain Inc

Red Mountain Inc (Oakland Park, FL) received a warning letter on March 20, 2019 based on the outcome of an inspection ending October 11, 2018.  The firm manufactures homeopathic products.  The firm used a contract manufacturing facility and FDA reminded them that they are responsible for the quality of the product produced regardless of any agreement in place with a CMO.  The warning letter also notes that one of the products is misbranded.

Deficiencies include but are not limited to:

  • Lack of a Quality Unit to provide oversight for homeopathic products produced from potentially toxic materials such as snake venom.
  • Management acknowledged the lack of a Quality Unit and the basic procedures that would ensure safety, identity, strength, quality and purity of the drug product.

DRUGS | King Bio Inc

King Bio Inc (Asheville, NC) received a warning letter on March 20, 2019 based on the outcome of an inspection ending July 20, 2018.  The firm manufactures homeopathic products.  The firm recalled all water-containing drugs after being contacted by FDA on August 23, 2018.  FDA also notes that products are misbranded and are new drugs distributed without the appropriate regulatory filings, and that they have an inadequate quality unit.  The firm is encouraged to hire qualified GMP consultant(s) to assist in bringing them into GMP compliance.

Deficiencies include but are not limited to:

  • An FDA laboratory tested products from the firm and found high levels of microbial contamination, including opportunistic pathogens.
  • The firm lacked adequate investigations into failing drug products, poor water quality and customer complaints.
  • Manufacturing processes have not been validated.  This concerns FDA because the firm manufactures various homeopathic drugs from ingredients that are potentially toxic (e.g., strychnine).
  • The purified water system is not validated, contains dead-legs and ball valves.  Microbial testing identified recurring TNTC results.

DRUGS | Dong Yuan Technology Co., Ltd.

Dong Yuan Technology Co., Ltd. (Shandong, China) received a warning letter on March 18, 2019 based on the outcome of an inspection ending September 28, 2018.  The firm manufactures OTC products.

Deficiencies include but are not limited to:

  • Forty-one test methods that the firm uses have not been shown to be equivalent to USP compendial methods.
  • The firm did not test the samples required by their SOP.  No deviations was initiated to justify this failure.
  • Process validation was not performed at the same scale at which the company is currently manufacturing for commercial distribution.
  • The firm did not retain laboratory data.  The laboratory worksheets only include final results.  No sample weights and calculations are retained.

DRUGS | Inopak Ltd.

Inopak Ltd. (Ringwood, NJ) received a warning letter on February 21, 2019 based on the outcome of an inspection ending July 20, 2018.  The firm manufactures antiseptic foam and hand wash for use in hospitals.  FDA states they identified observations that repeated those identified in a 2017 inspection.

Deficiencies include but are not limited to:

  • FDA’s testing identified failed microbial limit testing.  The firm says they thought the failing retest results were invalid due to testing error, and although they recalled the product they felt that nothing else was necessary.
  • The firm was unable to provide stability data supporting the labeled expiry.  The firm responded that there were “exploring options” and would update FDA on their plans.  
  • The firm does not have procedures applicable to the quality unit, including procedures for annual product review.  Further, annual product reviews were not conducted.
  • The firm did not validate the manufacturing process.

DEVICE | Inova Genomics Laboratory

Inova Genomics Laboratory received a warning letter on April 4, 2019 based on their advertising and sale of in vitro diagnostics test kits that are not cleared or approved, thus misbranded.  Read the press release here.


HUMAN CELL THERAPY | Cord for Life Inc

Cord for Life Inc (Altamonte Springs, FL) received a warning letter on March 29, 2019 based on the outcome of an inspection ending November 30, 2018.  The firm processes umbilical cord blood-derived cellular products for allogeneic use.  The warning letter includes several paragraphs about their authority as granted in 21 CFR 1271.

Deficiencies include but are not limited to:

  • The firm did not have appropriate procedures to prevent microbial contamination.  For example, they failed to validate aseptic processes since the beginning of manufacture of 2019; inspectors observed poor personnel practices; positive personnel EM results were not investigated.
  • The firm did not have adequate systems for environmental monitoring of areas engaged in aseptic processing.  
  • Cleaning processes of the BSCs are not validated.  
  • Manufacturing processes have not been validated.
  • Specifications, standards, sampling plans and test procedures have not been established; sterility testing used in release is not conducted on final product.
  • Expiry dating is not supported by stability data.  

 

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