FDA Inspection
McGuff Pharmaceuticals, Inc.McGuff Pharmaceuticals, Inc. – FDA Inspection, Jan 26, 2024
Record Details
This FDA Inspection record concerns McGuff Pharmaceuticals, Inc., with an inspection on January 26, 2024, issued by the Los Angeles District Office, covering human drugs.
View Company Profile
ID · 9da028b1-f0cc-456a-aa9e-f7ff6d6c6300
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228033
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.56(b)Written sanitation procedures lacking
Full citation text and observation details available on the Dashboard.
Other FDA inspections of McGuff Pharmaceuticals, Inc.
12| Date | Classification | Office | Project area |
|---|---|---|---|
| April 28, 2025 | OAI | Los Angeles District Office | Drug Quality Assurance |
| August 20, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 2, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for McGuff Pharmaceuticals, Inc.
- FDA Inspection 1268175 - 2025-04-28
- FDA Inspection 1229677 - 2024-08-20
- FDA Inspection 1110847 - 2019-11-22
- FDA Inspection 1083919 - 2019-03-26
- FDA Inspection 1013240 - 2017-06-02
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.