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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-214/
- Published: 2019-10-22T12:00:00.000Z
- Updated: 2026-09-15T01:58:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145309

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

**Jiangsu NHWA Pharmaceutical Co.**, Jiangsu, China (9/10): FDA inspected the firm in April and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the company failed to ensure that all sampling plans and test procedures are scientifically sound and appropriate to ensure that APIs conform to established standards of quality and purity. Jiangsu NHWA also failed to adequately investigate and document out-of-specification results according to procedures and implement appropriate corrective actions. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/jiangsu-nhwa-pharmaceutical-co-ltd-582511-09102019?ref=fdaweb.com).

**Sofie Co.**, Dulles, VA (10/10): FDA inspected the firm in April and cited GMP violations for positron emission tomography drugs. For example, Sofie’s facilities were found inadequate to prevent contamination of equipment or products by environmental conditions. FDA said environmental monitoring trend data frequently identified fungal contamination on operator glove, air, and surface samples. It noted that similar GMP violations were documented at another facility in your company's network, N-Molecular Inc. dba Sofie, which received a Warning Letter 9/24/2018\. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sofie-co-dba-sofie-583034-10102019?ref=fdaweb.com).