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FDA establishment 3008486071, Dallas, Texas, United States. Part of SOFIE's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 4
Official action indicated: 0
Last inspection ended: Apr 21, 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 212.30(b). Equipment procedures You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned and suitable for its intended purposes 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 15, 2019
Drugs · Drug Quality Assurance
5 cited references
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. 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.
21 CFR 212.70(e). When 30 hour rule is exceeded A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.
21 CFR 212.60(g)(5). Initials, signature, date Laboratory test records did not contain the initials or signature of the person performing the test.
21 CFR 212.20(e). Written QA procedures established, followed You did not follow written quality assurance procedures.
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
Dallas, Texas, United States. Part of