FDA establishment 3007834280, Tampa, Florida, United States. Part of PETNET Solutions's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
21 CFR 212.30(b). Equipment procedures You did not implement procedures to ensure that all equipment is suitable for its intended purposes and 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.
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 requirements of the FD&C Act as to safety and meets the quality and purity characteristics that it is supposed to have.
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.
Voluntary Action Indicated (VAI)
Jul 13, 2018
Drugs · Drug Quality Assurance
2 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 212.20(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 take appropriate corrective actions when necessary.
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