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FDA establishment 3009288779, San Juan, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.
Inspections: 4
Official action indicated: 0
Last inspection ended: Aug 21, 2026
Warning letters: 0
Recalls since 2016: 1
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(d). Supplies adequately controlled Your identity, purity and quality of supplies used in your testing procedures are not adequately controlled.
21 CFR 212.40(c). Use of reliable suppliers You did not use a reliable supplier as a source of each lot of component and container.
21 CFR 212.50(a). Written control procedures You did not have written production and process control procedures to ensure and document that all key process parameters are controlled.
21 CFR 212.20(d). Determination need for investigation When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary.
21 CFR 212.30(b). Equipment procedures You did not implement procedures to ensure that all equipment is properly installed, maintained, and capable of repeatedly producing valid results that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained.
Voluntary Action Indicated (VAI)
Jan 19, 2018
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Jul 22, 2016
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 212.70(f)(1)(iv). Correct malfunction, re-do test You approved a conditional final release of a PET drug product batch due to analytical equipment malfunction, but you did not document that reasonable efforts had been made to prevent recurrence of the malfunction.
Voluntary Action Indicated (VAI)
Dec 27, 2013
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Recalls
1 drug, device and biologic recalls since 2016, newest first; 0 Class I
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
San Juan, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations and its recalls since 2016.