SnugZ/USA, LLC
Form 483 issued September 17, 2021 · West Jordan, Utah
- Inspection
- Sep 13 – Sep 17, 2021
- Investigator
- Rafeeq Habeeb
- Observations
- 18
- Pages
- 7
- FEI number
- 3009188709
In short: On September 17, 2021, FDA issued a Form 483 with 18 observations to SnugZ/USA, LLC in West Jordan, Utah (FEI 3009188709) after an inspection that ran Sep 13 – Sep 17, 2021. The investigator was Rafeeq Habeeb. Most observations concern production 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 production.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Verification of the suitability of the testing methods is deficient in that they are not performed…
- 03
An adequate number of batches of each drug product are not tested to determine…
- 04
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Rafeeq Habeeb
20 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSnugZ/USA, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SnugZ/USA, LLC?
FDA listed 18 observations on this Form 483, mostly about production, 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 SnugZ/USA, LLC?
Rafeeq Habeeb is named on this Form 483, for the inspection of Sep 13 – Sep 17, 2021. Each investigator has a profile showing what they cite most.
When was SnugZ/USA, LLC inspected by FDA?
The inspection ran Sep 13 – Sep 17, 2021, and the Form 483 is dated September 17, 2021.
How do I get the full Form 483 for SnugZ/USA, LLC?
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.