Signature Formulations LLC
Form 483 issued November 9, 2017 · Phoenix, Arizona
- Inspection
- Oct 24 – Nov 9, 2017
- Investigator
- Nicholas L. Hunt
- Observations
- 10
- Pages
- 7
- FEI number
- 3011368010
In short: On November 9, 2017, FDA issued a Form 483 with 10 observations to Signature Formulations LLC in Phoenix, Arizona (FEI 3011368010) after an inspection that ran Oct 24 – Nov 9, 2017. The investigator was Nicholas L. Hunt. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and materials account for 6 of 10 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Procedures describing the warehousing of drug products are…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmSignature Formulations LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Signature Formulations LLC?
FDA listed 10 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Signature Formulations LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of Oct 24 – Nov 9, 2017. Each investigator has a profile showing what they cite most.
When was Signature Formulations LLC inspected by FDA?
The inspection ran Oct 24 – Nov 9, 2017, and the Form 483 is dated November 9, 2017.
How do I get the full Form 483 for Signature Formulations 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.