Week of June 10th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This was a busy week in contrast to the past two weeks in terms of posted warning letters.  Seven drug warning letters and one device warning letter were posted this week.

 

Be a leader in GMP intelligence.
Get our weekly regulatory newsletters free for a month.

 


DRUGS | Glint Cosmetics Pvt. Ltd

Glint Cosmetics Pvt. Ltd (Maharashtra, India) received a warning letter on May 31, 2019 based on the outcome of an inspection ending December 22, 2018.  The firm manufactures OTC products and cosmetics.

The FDA notes the firm is selling both unapproved new drugs and misbranded drugs, as well as drugs which are adulterated.  While the firm said they have “decided to suspend exports to the USA until all corrections are made…”, the FDA says they continued to ship products to the US through their distributor.  The firm was placed on import alert 66-40 on April 17, 2019.

The GMP deficiencies include but are not limited to:

  • The Quality unit did not provide adequate oversight for the manufacture of drug products.  The firm has hired a consultant to assist them in coming into GMP compliance.
  • The firm uses non-dedicated equipment to manufacture product and does not have validated cleaning processes.
  • The firm appears to have falsified records:
    • Our investigator also observed that your employees pre-filled and signed logbooks for cleaning and falsified the recorded duration of equipment cleaning.  For example, the cleaning of two “scoops” was documented at the exact same time, and for a duration of (b)(4) each day from September to December 2018, despite the facility being closed on some of those days.”
  • Control over computer systems is not adequate.  Analysts share the QC Manager login and password to the HPLC instruments.  CoA were stored in an unprotected area and could be modified without a record of the changes being captured.  In response to the warning letter the firm is required to provide information in the detailed three-part boilerplate language that FDA uses for the more egregious data integrity failures.

DRUGS | McDaniel Life-Line LLC

McDaniel Life-Line LLC (Felt, OK) received a warning letter on May 16, 2019 based on the outcome of an inspection ending November 16, 2018.

The firm is manufacturing and selling products that meet the requirement for a new drug but are not supported by an NDA or ANDA.  Thus, they are cited for unapproved new drug violations based on their label and website, misbranding because they do not provide adequate conditions for use, and finally manufacture under insanitary conditions.  FDA refers to the “filthy conditions” observed in the facility.

They were cited for violations of 21CFR211, including but not limited to:

  • Manufacture occurs in a residential kitchen and equipment is stored in a residential garage.
  • The firm lacks a quality unit to provide oversight of activities.  The firm responded that “The quality control is in the formulation of Indian Herb.”
  • The firm did not investigate a serious customer complaint.

DRUGS | Vida International Inc.  

Vida International Inc. (Taipei, Taiwan) received a warning letter on May 29, 2019 based on the outcome of an inspection ending December 13, 2018.   The firm manufactures OTC drugs and exports to the US.

The FDA states that the firm’s quality systems are inadequate and suggests they employ qualified consultants to assist them in coming into GMP compliance.  Their products were placed on import alert 66-40 on March 11, 2019.

Deficiencies include but are not limited to:

  • The firm released product without testing of final product.   This is a common deficiency identified in warning letters to OTC manufacturers.
  • The firm did not test incoming raw materials for identity before use and used material without CoA information.
  • The firm lacked a Quality Control unit.
  • Batch production record did not include specifics such as all inactive ingredients on the product label, calculation of theoretical or actual yield, documentation of equipment used and critical manufacturing parameters.

DRUGS | University Fertility Laboratory

University Fertility Laboratory (Torrance, CA) received a warning letter on May 30, 2019 based on the outcome of an inspection ending February 4, 2019.

The firm was cited for deviations from 21CFR1271, regulations for human cells, tissues, and cellular and tissue-based products.  Additional deviations, beyond those on the form 483 issued at the close of inspection, were identified after additional review of donor records and procedures that were gathered during the inspection.

Deficiencies include but are not limited to:

  • Failure to test donors for relevant communicable diseases.
  • Failure to screen a donor by reviewing their relevant medical records for risk factor and evidence of communicable disease.
  • Failure to identify the person who made the decision about donor eligibility.
  • Oocyte donors were determined to be eligible prior to the receipt of all required testing for communicable diseases.
  • Failure to establish and maintain procedures for all steps in testing, screening and determination of donor eligibility.
  • FDA also provides feedback on the revised donor eligibility questionnaire.

DRUGS | Ingenue Care

Ingenue Care (Norwalk, CA) received a warning letter on May 31, 2019 based on the outcome of an inspection ending December 6, 2018.  The firm manufactures a long list of OTC products and did not respond to the form 483 issued at the end of the inspection.

The firm also distributes new drugs without an NDA or ANDA.  FDA provides a long list of deficiencies in product labeling including failure to comply with the Tentative Final Monograph for external analgesic drug products of OTC human use.  Finally, they suggest the firm employ a qualified consultant to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The firm did not conduct adequate testing for identity and strength of each active ingredient.  Also, they lacked testing for total aerobic microbial count and objectionable micro organisms.
  • The firm accepted APIs and other components on the basis of the CoA from the supplier without establishing the reliability of the supplier’s analysis.  An identity test is not conducted for each component.
  • The firm did not have stability data to support expiry dating.
  • The firm lacked a Quality unit and the necessary procedures.

DRUGS | Advanced Botanical Consulting and Testing Inc. dba ABC Testing

Advanced Botanical Consulting and Testing Inc. dba ABC Testing (Tustin, CA) received a warning letter on June 4, 2019 based on the outcome of an inspection ending November 13, 2018.

Deficiencies include but are not limited to:

  • The firm did not use USP monograph methods to test USP monograph products and did not show equivalency of the methods they used to the USP method.
  • Notebooks and laboratory worksheets lack documentation of lot numbers and expiration dates of standards.
  • The firm has disabled audit trails and does not restrict users from altering data.
  • Many pieces of equipment were out of calibration or not qualified.  Also, spreadsheets used in calculation of results were not validated.

DRUGS | Spectrum Laboratory Products

Spectrum Laboratory Products (Gardena, CA) received a warning letter on June 4, 2019 based on the outcome of an inspection ending November 16, 2018.  The firm manufactures APIs.

The firm does not provide accurate drug listing to the FDA.  Also, a variety of products the firm distributes are misbranded.  FDA recommends the firm employ qualified consultants to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The firm omitted the original manufacturer from the COA of repackaged APIs.  The firm distributed opioid APIs to customers with incomplete information.
  • The firm did not document adequate investigations and determine root cause and identify corrective actions.  The firm also fails to adequately investigate customer complaints.
  • The firm did not test the glycerin they distributed for the DEG contaminant.

DEVICES | OriGen Biomedical, Inc

OriGen Biomedical, Inc (Austin, TX) received a warning letter on December 20, 2018 based on the outcome of an inspection ending July 5, 2018.  The firm manufactures dual lumen catheters.

Deficiencies include but are not limited to:

  • The firms have not established procedures to control products that do not conform to requirements.  Reworked catheters failed endotoxin tests but were released and distributed. Further, the catheters were sterilized a second time with ethylene oxide but there is no documentation to ensure that product is not adversely impacted.
  • Production drawings were incomplete or incorrect.
  • The firm did not submit MDR reports as required, nor did they have adequate MDR procedures.

Like this & want more?
Sign up to get free weekly content updates
designed to make your job easier
.

 

Learn more about how FDAzilla can help you achieve your quality and inspection preparation goals: get 483sInspectorProfilesEnforcement Analytics, and GMP Regulatory Intelligence. Contact us if you ever have questions at sales@fdazilla.com.

 

About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.  Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

Like this post? Don't forget to share it!

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

Recent Posts

Experience the Power of FDAzilla

Get your FREE account to search sites, inspections, & warning letters