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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-102/
- Published: 2017-02-28T12:00:00.000Z
- Updated: 2026-09-14T22:08:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138091

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**Chongqing Pharma Research Institute Co.** Chongqing (2/14): FDA inspected the firm 5/2016 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards. FDA investigators reviewed audit trails from various stand-alone pieces of laboratory equipment used to perform high performance liquid chromatography and gas chromatography analyses, and they found entire chromatographic sequences were deleted from stand-alone computers. The firm also repeated analyses until acceptable results were obtained, and it failed to investigate original out-of-specification or otherwise undesirable test results. FDA recommended that the firm retain a qualified consultant to assist in remediation of data integrity concerns.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543347.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543347.htm?ref=fdaweb.com)

  
**Pfizer Inc.** New York, NY (2/14): FDA inspected the firm’s Hospira McPherson, KS facility 5/2016 and cited significant GMP violations involving finished pharmaceuticals and delinquent field alert reports. The inspection revealed that the firm failed to thoroughly investigate an unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Reports were reviewed from multiple investigations into complaints about the presence of visible particulates in several sterile injectable products. FDA documented that the investigations into these product quality defects were inadequate and failed to spur appropriate corrective actions and preventive actions.  
[https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm542587.htm](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm542587.htm?ref=fdaweb.com)