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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-3/
- Published: 2019-11-19T12:00:00.000Z
- Updated: 2026-09-14T15:53:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145539

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

**A.P. Deauville**, New Brunswick, NJ (11/8): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, it failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the company failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ap-deauville-llc-586306-11082019?ref=fdaweb.com).  

**Apothecus Pharmaceutical Corp.**, Hicksville, NY (11/8): FDA inspected the firm in April and cited significant GMP violations for combination products. For example, it failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. Additionally, Apothecus failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/apothecus-pharmaceutical-corp-585666-11082019?ref=fdaweb.com).  
  
**Carolina Liquid Chemistries**, Winston Salem, NC (7/31): FDA inspected the firm 11/2018 and cited violations with its in-vitro diagnostic reagents. The agency said the firm’s Tapentadol Reagent Kit ST431 Lot #11666, CLC720 Zolpidem (Zolp) Reagent Kit ST428 Lot #11433, Spice Kit Lot #J1814, and Fentanyl (Fent) Kit Lot #E1815 lack a cleared 510(k) or approved PMA. Despite certain devices with “Instructions for Use” stating the devices are “for forensic use only,” FDA said there is no evidence that the reagents are used for such purposes. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/carolina-liquid-chemistries-corp-573596-07312019?ref=fdaweb.com).  

**Torrent Pharma**, Basking Ridge, NJ (10/28): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, it failed to use adequate equipment in the manufacture, processing, packing, or holding of drug products. Torrent also failed to thoroughly investigate failing microbiological results from its water system. The letter also strongly recommended that the firm retain a consultant to help meet GMP requirements. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/torrent-pharma-inc-584701-10282019?ref=fdaweb.com).