FDA Inspection
Signature Formulations, LLCSignature Formulations, LLC – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns Signature Formulations, LLC, with an inspection on November 9, 2017, issued by the Denver District Office, covering human drugs.
View Company Profile
ID · c94b1607-9395-4994-bd00-4ad915f39ef8
Inspection Facts
- Inspection number
- 1031084
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Signature Formulations, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 29, 2025 | Not classified | Denver District Office | Drug Quality Assurance |
| November 22, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 30, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 19, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Signature Formulations, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.