Drug factory · FDA FEI 3042513702
Shine Spect USA,LLC
325 Treble Cove Rd, North Billerica, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 10, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2026: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bicisate | Makes it, tests it, packages it and labels it | Shine Spect USA, LLC | 87333-006 |
| Technetium Tc-99m Pertechnetate | Makes it, packages it and labels it | Shine Spect USA, LLC | 87333-090, 87333-091 |
| Tetrakis(2-Methoxyisobutylisocyanide)copper(i) Tetrafluoroborate | Makes it, tests it, packages it and labels it | Shine Spect USA, LLC | 87333-001 |
| Xenon Xe-133 | Makes it | Shine Spect USA, LLC | 87333-127, 87333-128 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 10, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 10, 2026 inspection
- Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure, micro-organisms and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.