McGuff Pharmaceuticals, Inc.
Form 483 issued January 26, 2024 · Santa Ana, California
- Inspection
- Jan 16 – Jan 26, 2024
- Investigators
- Michael T. Cyrus· Pearl C. Ozuruigbo
- Observations
- 6
- Pages
- 8
- FEI number
- 2022073
In short: On January 26, 2024, FDA issued a Form 483 with 6 observations to McGuff Pharmaceuticals, Inc. in Santa Ana, California (FEI 2022073) after an inspection that ran Jan 16 – Jan 26, 2024. The investigators were Michael T. Cyrus and Pearl C. Ozuruigbo. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Quality system and production account for 4 of 6 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
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Deviations from written production and process control procedures are…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
This inspection in context
Michael T. Cyrus
12 documents · 2021–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmMcGuff Pharmaceuticals, Inc. history
All 3 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 McGuff Pharmaceuticals, Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, production 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 McGuff Pharmaceuticals, Inc.?
Michael T. Cyrus and Pearl C. Ozuruigbo are named on this Form 483, for the inspection of Jan 16 – Jan 26, 2024. Each investigator has a profile showing what they cite most.
When was McGuff Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Jan 16 – Jan 26, 2024, and the Form 483 is dated January 26, 2024.
How do I get the full Form 483 for McGuff Pharmaceuticals, Inc.?
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.