Drug factory · FDA FEI 3012030543

Brigham and Women`s Hospital, Inc., the

75 Francis Street, Boston, MA, United States

Problems found, fixed voluntarily at FDA's last inspection, Jun 22, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2014: 1 with no problems, 2 with problems fixed voluntarily, 2 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ammonia N-13	Makes it	Brigham and Women's Hospital, Inc., The	24450-113
Fludeoxyglucose F-18	Makes it	Brigham and Women's Hospital, Inc., The	24450-647

Ended	Result	Program	Problems noted
Jun 22, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1
Apr 11, 2023	No problems found	Drug Quality Assurance	—
Sep 16, 2021	Serious problems, FDA action	Drug Quality Assurance	5
Aug 22, 2019	Serious problems, FDA action	Drug Quality Assurance	5
Aug 15, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
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.

Determination need for investigation 21 CFR 212.20(d)
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.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
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.
Equipment procedures 21 CFR 212.30(b)
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.
Lab sampling and test procedures 21 CFR 212.60(b)
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.

Adverse effects of changes made 21 CFR 212.20(c)
You did not demonstrate that any change does not adversely affect the identity, strength, quality and purity of your PET drug.
Determination need for investigation 21 CFR 212.20(d)
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.
Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
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.
Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use.

Registered with FDA for: positron emission tomography drug production.