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US FDA Issues Warning Letter to DeGrave Dairy for Illegal Drug Residue

On February 27, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to the two owners of DeGrave Dairy. This Warning Letter was issued  for violations of the Federal Food, Drug, and Cosmetic Act (the Act).

DeGrave Dairy is a dairy operation that the Minneapolis District inspected for three days .  The violations included

–Presence of Penicillin Residues above limits.

View the full Hospira US FDA Warning Letter

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US FDA Issues Warning Letter to Lucky Pacific Corp and Kamli International Co. Ltd.

On March 2, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to seafood importers,  Lucky Pacific Corp and Kamli International Co. Ltd. This Warning Letter was issued for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.  These violations cuased the ready-to-eat dried fish snacks and ready-to-eat dried fish skin snacks to be adulterated.

The New York District Office  inspected Lucky Pacific Corp and Kamli International Co. Lt  for two days in October.  The violation was for the firms not providing the required affirmative step to  ensure that imported fish products are processed in accordance with the seafood HACCP Regulation.

View the Full US FDA Warning Letter

 

 

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Hospira Warning Letter Issued by US FDA

On February 14, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hospira. This Warning Letter was issued  for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.   These violations lead to the drug products beingadulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Hospira is a drug manufacturing facility owned by Pfizer.  The Kansas City District Office  inspected Hospira for nearly a month between May 16 to June 8, 2016. .  The violations included

–Failure to submit field alert reports to FDA

–Failure to thoroughly investigate unexplained discrepancies or failures of a drug batch to meet  specifications

–Failure to have valid in-process specifications

–Failure to follow  procedures to prevent microbiology contamination of  sterile drugs

–Failure to control rejected in-process materials

–Failure to establish laboratory controls

–Repeat violations at multiple facilities.

View the full Hospira US FDA Warning Letter

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FDA Warning Letter Issued to Hebei Yuxing Bio-Engineering Co Ltd

On September 6, 2016, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hebei Yuxing Bio-Engineering Co Ltd. This Warning Letter was issued by the US FDA’s Center for Drug Evaluation and Research (CDER) for current Good Manufacturing Practices cGMP violations during manufacture of Active Pharmaceutical Ingredient (API) which resulted in in the API’s being adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetics Act (FD&C Act).

Hebei Yuxing is a firm in China that was inspected between August 17 to 21, 2015. Because of the violations, the firm was placed on Import Detention on July 8, 2016. The violations included

          The quality system does not adequately ensure the accuracy and integrity of data.
          Failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures.
      Failure of the quality unit to ensure that all critical deviations are investigated and resolved.
      The quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs
The full US Food and Drug Administration Warning Letter maybe viewed here:  http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm521098.htm