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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-86/
- Published: 2016-10-11T12:00:00.000Z
- Updated: 2026-09-14T21:38:46.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5137048

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

**CFP Acquisitions, Inc.** (dba The Apothecary Shoppe) Broken Arrow, OK (8/19). FDA inspected pharmacy compounding operations in March and noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it was producing. The investigators also found that the firm produces domperidone products, which do not have official monographs. Furthermore, FDA investigators observed that the firm produced a drug product (potassium chloride) that appears on the agency’s list of drugs that have been withdrawn or removed from the market because they have been found to be unsafe or not effective.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524082.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524082.htm?ref=fdaweb.com)

**Delarange Cosmetics & Healthcare BV** Zeewolde, The Netherlands (9/29). FDA inspection in June documented GMP violations involving finished pharmaceuticals. The firm’s Form 483 response indicates it no longer will produce products for the U.S. market, and therefore it declined to address any of the violations.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524124.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524124.htm?ref=fdaweb.com)

**Laboratoire Sintyl S.A.** Geneva, Switzerland (9/29). FDA inspected the firm in June and documented GMP violations. The firm indicated in its Form 483 response that it no longer was manufacturing over-the-counter drug products for the U.S. market.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524002.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524002.htm?ref=fdaweb.com)

**Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd**. Yangzhou, Jiangsu, China (9/26). FDA inspected the firm in January and documented serious GMP violations. The firm failed to provide adequate written production and control procedures. Samples collected at port of entry found the products did not contain any of the labeled active ingredient. The firm also does not have appropriate laboratory analyses to determine products conform to final specifications. FDA placed the firm and its products on import alert in August.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524001.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524001.htm?ref=fdaweb.com)