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# ‘Serious Deficiencies’ at Atlantic Pharmacy and Compounding
- URL: https://www.fdaweb.com/serious-deficiencies-at-atlantic-pharmacy-and-compounding/
- Published: 2018-11-06T12:00:00.000Z
- Updated: 2026-09-15T00:42:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142748

A 6/26-7/20 FDA inspection at Vital Rx, doing business as Atlantic Pharmacy and Compounding, Pompano Beach, FL, found “serious deficiencies” in the firm’s practices for producing drug products, which put patients at risk. A just-released 9/26 [notice of violation](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm624489.htm?ref=fdaweb.com) says drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the products to be considered adulterated. It lists nine examples of insanitary conditions.

In the letter, the agency acknowledges that the firm ceased drug production 7/20/17 and recalled all lots of unexpired compounded injectable drug product 8/17/17\. It also acknowledges a 9/5/17 Florida Department of Health order for the emergency restriction of the firm’s special sterile compounding permit.

“FDA strongly recommends that if you decide to resume production of sterile drugs, your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” the letter says. “In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug processing expertise should assist you in conducting this comprehensive evaluation.”

The company, which did not respond to the FDA-483 issued at the end of the inspection, was told to respond with a list of any steps that have been taken to correct the violations in the letter or to indicate that there is no plan to resume production of sterile drugs. If the firm intends to resume production of sterile drugs, FDA says, it should explain each step being taken to prevent the recurrence of violations, with documentation of each step.