SmartScience Laboratories, Inc.
Form 483 issued November 22, 2024 · Tampa, Florida
- Inspection
- Nov 18 – Nov 22, 2024
- Investigator
- Dorothy P. Kramer
- Observations
- 8
- Pages
- 9
- FEI number
- 3003929069
In short: On November 22, 2024, FDA issued a Form 483 with 8 observations to SmartScience Laboratories, Inc. in Tampa, Florida (FEI 3003929069) after an inspection that ran Nov 18 – Nov 22, 2024. The investigator was Dorothy P. Kramer. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
The number of qualified personnel is inadequate to perform and supervise the manufacture, processing, packing and…
- 04
Each component is not added to the batch by one person and verified…
This inspection in context
Dorothy P. Kramer
9 documents · 2022–2025
Cites 211.22(d) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmSmartScience Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SmartScience Laboratories, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected SmartScience Laboratories, Inc.?
Dorothy P. Kramer is named on this Form 483, for the inspection of Nov 18 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was SmartScience Laboratories, Inc. inspected by FDA?
The inspection ran Nov 18 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for SmartScience Laboratories, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.