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FDA establishment 3012030543, Boston, Massachusetts, United States. Part of Brigham and Women's Hospital's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 6
Official action indicated: 2
Last inspection ended: Jun 22, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 2 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(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)
Apr 11, 2023
Drugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Sep 16, 2021
Drugs · Drug Quality Assurance
5 cited references
21 CFR 212.60(b). Lab sampling and test procedures Each laboratory did not have testing procedures which are designed to ensure that PET drug products conform to appropriate standards including established standards of identity, strength, quality and purity.
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 and conduct an investigation when necessary.
21 CFR 212.30(b). Equipment procedures You did not implement procedures to ensure that all equipment is cleaned, 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 212.30(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(e). Written QA procedures established, followed You did not follow written quality assurance procedures.
Official Action Indicated (OAI)
Aug 22, 2019
Drugs · Drug Quality Assurance
5 cited references
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 212.20(e). Written QA procedures established, followed You did not establish and follow written quality assurance procedures.
21 CFR 212.60(c). Analytical methods Your laboratory analytical methods are not suitable for their intended use.
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(c). Adverse effects of changes made You did not demonstrate that any change does not adversely affect the identity, strength, quality and purity of your PET drug.
21 CFR 803.30(a)(1). Report of Death Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to within ten working days after becoming aware of information that reasonably suggests that a device has or may have caused or contributed to the death of a patient of the facility.
21 CFR 803.18(a). Event files -- failure to establish and maintain MDR event files have not been established and maintained.
21 CFR 803.30(a)(2). Report of Serious Injury Within 10 Days The user facility did not submit FDA Form 3500A or electronic equivalent to the known device manufacturer within 10 working days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility.
21 CFR 803.17. Lack of Written MDR Procedures Written MDR procedures have not been developed and maintained and implemented .
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
Boston, Massachusetts, United States. Part of