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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-97/
- Published: 2017-01-24T12:00:00.000Z
- Updated: 2026-09-14T22:02:43.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137806

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

**Porton Biopharma**, Salisbury, United Kingdom (1/19): FDA inspected the firm’s facility 3/2016 and cited significant GMP violations. The agency cited similar GMP violations in a 2015 inspection. The current inspection cited the firm for inadequately investigating particulate matter in several batches of Erwinaze lyophilized powder for injection that exceeded established action limits. FDA also cited the firm for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination. The letter notes that the firm and its customer, Jazz Pharmaceuticals, have a quality agreement and both are responsible for the quality of drugs released and ultimately administered to patients. Because these violations and deviations are significant and repeated, the agency said corrective action should be taken as soon as possible. FDA indicated it will contact the firm to schedule a face-to-face regulatory meeting.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538105.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm538105.htm?ref=fdaweb.com)

**Walter’s Pharmacy** Allentown, PA (1/11): FDA inspected the firm 2/2016 and determined that the compounding pharmacy was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. In addition, the agency investigator observed serious deficiencies in the firm’s practices for producing sterile drug products.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm537346.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm537346.htm?ref=fdaweb.com)