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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-95/
- Published: 2016-12-13T12:00:00.000Z
- Updated: 2026-09-14T21:54:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137556

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

**Pocono Coated Products** Cherryville, NC (10/27): FDA inspected the firm 10/2015 and documented significant GMP violations related to finished pharmaceuticals. For example, FDA cited the firm for not having an appropriate laboratory determination of satisfactory conformance to final specifications for drug products before releasing them. Samples collected by the agency found sub-potent products. The firm was also cited for failing to validate the manufacturing process for certain transdermal patches. Additionally, the firm was cited for having master batch records that lacked a statement of theoretical yield, percentage of theoretical yield, and statements of limits beyond which an investigation is required.

[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532706.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532706.htm?ref=fdaweb.com)

**United Contact Lens** Arlington, Washington (11/30): FDA inspected the firm 10/4-12 and documented GMP and quality system deviations with its soft contact lens manufacturing (United 55, SonicView, and TreSoft). For example, the firm failed to establish and maintain purchasing control procedures for the evaluation of suppliers, contractors, and consultants. This was a repeat observation from an inspection in 2013\. The firm also failed to document Medical Device Report reportability on customer complaint forms as per firm’s procedures. Additionally, the inspection cited the firm’s procedure on calibrating certain equipment because it did not require performance of calibrations using calibration standards that are traceable to national or international standards. [http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532322.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm532322.htm?ref=fdaweb.com)