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FDA establishment 3014201471, Jacksonville, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 2
Official action indicated: 0
Last inspection ended: Jul 17, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 212.60(c). Analytical methods Your laboratory analytical methods are not sufficiently accurate.
21 CFR 212.30(a). Orderly handling, prevention of mix-ups, prevention of contamination Your facilities are not adequate to ensure the orderly handling of materials and equipment, the prevention of mix-ups and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality.
21 CFR 212.50(b)(7). Complete instructions, procedures, specs Your master production and control records did not include complete special notations and precautions to be followed.
21 CFR 212.40(c). Use of reliable suppliers You did not use a reliable supplier as a source of each lot of component, container and closure.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. Recalls come from FDA's enforcement reports (iRES), one row per recall even when it covers many lots. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard, warning letters and enforcement reports
Jacksonville, Florida, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.