Signature Formulations LLC
Form 483 issued September 30, 2021 · Phoenix, Arizona
- Inspection
- Sep 16 – Sep 30, 2021
- Investigators
- Alan M. Barker· Christopher M. Jenner
- Observations
- 7
- Pages
- 9
- FEI number
- 3011368010
In short: On September 30, 2021, FDA issued a Form 483 with 7 observations to Signature Formulations LLC in Phoenix, Arizona (FEI 3011368010) after an inspection that ran Sep 16 – Sep 30, 2021. The investigators were Alan M. Barker and Christopher M. Jenner. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Laboratory controls and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The written stability testing…
- 03
There is no quality…
- 04
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Alan M. Barker
10 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Michigan.
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 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Signature Formulations LLC?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, quality system and production. 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?
Alan M. Barker and Christopher M. Jenner are named on this Form 483, for the inspection of Sep 16 – Sep 30, 2021. Each investigator has a profile showing what they cite most.
When was Signature Formulations LLC inspected by FDA?
The inspection ran Sep 16 – Sep 30, 2021, and the Form 483 is dated September 30, 2021.
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.