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

Warning letters posted this week include ones demonstrating FDA’s continued focus on over-the-counter (OTC) product manufacturers and manufacturers in India, including a particularly testy letter to Pfizer for a Hospira site in India that they are closing.  Lupin announced that they received a warning letter, but it has not been posted by the FDA yet.

DRUGS | Lupin

Lupin revealed that they received a warning letter, though it has not yet been published on the FDA website.

This warning letter follows inspection of two plants in December 2018 that resulted in a 25-page form 483 that included 19 total observations.  Hopefully it will be available next week and we will publish it.

DRUGS | Laboratorios Quanium LLC

Laboratorios Quanium LLC (Medley, FL) received a warning letter on February 25, 2019 based on the outcome of an inspection ending August 2, 2018.  The firm manufactures OTC drug products.

In addition to GMP violations, at least one product is an unapproved new drug.  The FDA recommends that the firm hire a consultant to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • The firm did not have a quality unit and was missing basic GMP procedures.  Further, the office manager released lots of material that failed potency determinations.
  • Incoming components were not tested prior to release.  Rather, the firm relied on the vendor’s certificate of analysis.
  • Equipment labeled as clean was observed with unidentified brown stains on product contact surfaces, white residues and brown stagnant water in the holding tank of the filling machine, and water in transfer hoses.
  • The firm did not perform process validation but has released batches in the US since 2013.
  • The four-year expiry date on product is not supported by real-time data.

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DRUGS | Anicare Pharmaceutical Pvt Ltd.

Anicare Pharmaceutical Pvt Ltd (Mumbai, India) received a warning letter on February 28, 2019 based on the outcome of an inspection ending August 3, 2018.  The firm manufactures a variety of OTC products.

Deficiencies include but are not limited to:

  • The stability program did not include testing for microbial attributes.
  • Filling operations were not validated nor was homogeneity demonstrated throughout the batch.  Though redacted is well done, it appears that the water system has not been validated and is deficient.
  • Cleaning validation is inadequate.

DRUGS | Jubilant Generics Limited

Jubilant Generics Limited (Uttar Pradesh, India) received a warning letter on March 6, 2019 based on the outcome of an inspection ending August 8, 2018.

FDA notes that these represent repeat problems from the April 2016 inspection, and recommends the firm identify qualified consultant(s) to assist them in coming into GMP compliance.

Deficiencies include but are not limited to:

  • Investigations into deviations and complaints were inadequate.
  • The firm failed to test and reject in-process materials that did not conform to testing.  This was associated with a change control that added a test in February 2017.

DRUGS | Hospira Healthcare India Pvt. Ltd.

Hospira Healthcare India Pvt. Ltd  (Tamil Nadu, India) received a warning letter on March 4, 2019 based on the outcome of an inspection ending April 3, 2018.

The warning letter was sent to their corporate parent, the CEO of Pfizer.  The firm has stopped production and distribution of drug products from the site “due to the significant long term loss of product demand.”  Further, the firm was placed on import alert on August 1, 2018.  The FDA also states that “..remediating these CGMP violations will be necessary if Pfizer, a successor, or an acquirer resumes drug manufacturing operations at this site for the U.S. market.”

Deficiencies include but are not limited to:

  • Failure to accurately report microbiological test results.  Plates which had visible growth were reported as no growth.
    • Further, FDA states The critical data integrity breaches identified in our inspection also raise serious concerns regarding the validity of all results reported by your quality control laboratory.”
  • The firm failed to adequately investigate poor control and critical defects in the manufacturing process.
  • Tests which had previously been reported as passing were repeated under FDA requested testing and observation, all were out of specification (OOS).
  • The quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs manufactured.  In response, the firm is asked to provide:
    • A comprehensive investigation into the extent of the inaccuracies in data records and reporting.
    • A current risk assessment of the potential effects of these observed failures on the quality of the drugs. The assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
    • A management strategy for the firm that includes the details of global corrective action and preventive action plan.

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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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