SmartScience Laboratories, Inc.
Form 483 issued December 10, 2018 · Tampa, Florida
- Inspection
- Nov 27 – Dec 10, 2018
- Investigator
- Christos G. Tsingelis
- Observations
- 5
- Pages
- 5
- FEI number
- 3003929069
In short: On December 10, 2018, FDA issued a Form 483 with 5 observations to SmartScience Laboratories, Inc. in Tampa, Florida (FEI 3003929069) after an inspection that ran Nov 27 – Dec 10, 2018. The investigator was Christos G. Tsingelis. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Materials and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
There was a failure to handle and store drug product containers at all times in a…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 04
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
This inspection in context
Christos G. Tsingelis
2 documents · 2018
Cites 211.113(a) (control of microbiological contamination) 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 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SmartScience Laboratories, Inc.?
FDA listed 5 observations on this Form 483, mostly about materials, laboratory controls and production. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected SmartScience Laboratories, Inc.?
Christos G. Tsingelis is named on this Form 483, for the inspection of Nov 27 – Dec 10, 2018. Each investigator has a profile showing what they cite most.
When was SmartScience Laboratories, Inc. inspected by FDA?
The inspection ran Nov 27 – Dec 10, 2018, and the Form 483 is dated December 10, 2018.
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.