Week of March 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

This week there were a handful of warning letters issued to drug manufacturers.  FDA continues an unrelenting focus on over-the-counter (OTC) (including cosmetics and sunscreen) and contract manufacturers.

DRUGS | Becton Dickinson Medical Systems

FDA published a close-out letter to Becton Dickinson Medical Systems regarding a warning letter the firm received on September 14, 2018.

DRUGS | New Era Naturals LLC

New Era Naturals LLC (Durango, CO) received a warning letter on January 30, 2019 based on the outcome of an inspection ending April 13, 2018.  The firm manufactures OTC products, including sunscreens.

Deficiencies include but are not limited to:

  • The firm released product without performing any final product testing including identity and strength of the active ingredient.
  • Incoming raw materials are not tested.  In response, the firm said they would now use the vendor’s Certificate of Analysis (CoA) to establish quality attributes. That was the wrong answer according to the FDA.
  • The firm does not have master product records or batch production records.  The ones that the firm prepared during the inspection were missing key information which the FDA identifies in bullet points in the warning letter.
  • The firm does not have an established quality unit nor do they have procedures defining the roles and responsibilities of the quality unit.
  • Registration and listing violations were also identified by the FDA.

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DRUGS | Actavis Laboratory

Actavis Laboratory (Davie, FL) received a warning letter on February 1, 2019 based on the outcome of an inspection ending July 19, 2019.

FDA notes that similar deficiencies were identified at three previous inspections in 2013, 2016, 2017.  They also note that the firm does not have an adequate ongoing process monitoring program. The company is owned by Teva, an asset acquired when purchasing Allergan’s generics business in 2016.

Deficiencies include but are not limited to:

  • The laser drilled hole process is not sufficiently validated to ensure it is under control. Changes were made by the engineers outside of the change management system.  Further changes were made to the vision inspection system that were not fully evaluated.
  • Not adequately qualified operators performed in-process inspections of the laser drilled dosage products.
  • The Quality unit did not provide adequate oversight of the laser drilling process including process validation, inspection, change management and maintenance of critical manufacturing equipment.
  • The firm did not adequately address process failures and put effective CAPAs in place.

DRUGS:  Vilvet Pharmaceuticals

Vilvet Pharmaceuticals (Chester Springs, PA) received a warning letter on February 25, 2019 based on the outcome of an inspection ending June 27, 2018.

The firm also had drug listing violations and issues with the dietary supplements they manufacture.  FDA suggests they employ a consultant to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The firm uses a contract manufacturer and states that the CMO is responsible for lot release.
  • The firm does not have SOPs supporting basic activities or if they were present they were inadequate.

DRUGS | Andapharm LLC

Andapharm LLC (Fort Lauderdale, FL) received a warning letter on February 28, 2019 based on the outcome of an inspection ending July 18, 2018.

The warning letter identifies the firm as a contract manufacturer.

Deficiencies include but are not limited to:

  • Equipment is held for extended periods of time prior to cleaning and the interval is not supported by validation.  This is a repeat observation from 2012 and 2016.
  • Stability studies for multiple products lack information on tests, storage conditions and duration of the study.  This is also a repeat identified in the 2012 and 2016 inspections.
  • Rejected lots of drug product were not labeled as such, nor were they documented in the ‘reject book’.
  • GMP information was not always recorded on controlled documentation.  Rather, uncontrolled notebooks and loose sheets of paper were used.

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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

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