Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
21 CFR 212.30(a). Orderly handling, prevention of mix-ups, prevention of contamination Your facilities are not adequate to ensure 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(c)(7). ID of major equipment Your batch production record did not include the identification of major pieces of equipment used in production of the batch.
21 CFR 212.20(a). Oversight of production operations You did not oversee production operations in a manner to ensure that each PET drug meets the quality and purity characteristics that it is supposed to have.
21 CFR 212.50. Adequate controls (general) Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Voluntary Action Indicated (VAI)
Mar 20, 2018
Drugs · Bioresearch Monitoring
3 cited references
21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the evaluation of post marketing adverse drug experiences.
21 CFR 314.81(b)(2). Timely submission An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
21 CFR 314.80(c)(2). Late submission of quarterly safety reports Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
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. 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 and warning letters
Houston, Texas, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.