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# Sterile Drug Issues in Vitalab Inspection
- URL: https://www.fdaweb.com/sterile-drug-issues-in-vitalab-inspection/
- Published: 2019-02-14T12:00:00.000Z
- Updated: 2026-09-15T01:04:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143385

A 3/26-4/4/18 FDA inspection at Vitalab Pharmacy, Phoenix, AZ, found “serious deficiencies in your practices for producing sterile drug products, which put patients at risk,” according to a just-released 1/10 [Warning Letter](https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm631109.htm?ref=fdaweb.com). The letter acknowledges that on 4/4/18, upon receipt of an FDA-483, the company ceased sterile drug production under a laminar airflow hood and on 4/24/18 voluntarily recalled all products intended to be sterile that were produced using the laminar hood.

The letter says drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, in which they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated.

FDA acknowledges the firm’s response to the FDA-483 and says it cannot fully evaluate the adequacy of some of Vitalab’s corrective actions because the company did not include sufficient information or supporting documentation.

“FDA strongly recommends that your management 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 manufacturing expertise should assist you in conducting this comprehensive evaluation.”

Vitalabs was told to take prompt action to correct the violations and to respond with a list of specific steps taken, with a timetable for completion. It also is to notify FDA 15 days before resuming production of any sterile drugs using the laminar airflow hood.

The company also was [warned](http://fdaweb.com/login.php?sa=v&aid=D5130230&searchWords=vitalab&cate=S&stid=%241%243I2.OZ%2F.%24ivZFBfwykDO4blEjdwsu6.&ref=fdaweb.com) by FDA in 2014.