Ecometics, Inc
Form 483 issued February 6, 2023 · Norwalk, Connecticut
- Inspection
- Dec 12, 2022 – Feb 6, 2023
- Investigator
- Jonah S. Ufferfilge
- Observations
- 9
- Pages
- 16
- FEI number
- 1250013
In short: On February 6, 2023, FDA issued a Form 483 with 9 observations to Ecometics, Inc in Norwalk, Connecticut (FEI 1250013) after an inspection that ran Dec 12, 2022 – Feb 6, 2023. The investigator was Jonah S. Ufferfilge. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
You failed to perform cleaning validations to evaluate critical parameters such as clean and dirty hold…
- 03
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Jonah S. Ufferfilge
17 documents · 2019–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmEcometics, 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 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ecometics, Inc?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, quality system and materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Ecometics, Inc?
Jonah S. Ufferfilge is named on this Form 483, for the inspection of Dec 12, 2022 – Feb 6, 2023. Each investigator has a profile showing what they cite most.
When was Ecometics, Inc inspected by FDA?
The inspection ran Dec 12, 2022 – Feb 6, 2023, and the Form 483 is dated February 6, 2023.
How do I get the full Form 483 for Ecometics, 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.