McGuff Pharmaceuticals, Inc.
Form 483 issued March 26, 2019 · Santa Ana, California
- Inspection
- Mar 18 – Mar 26, 2019
- Investigator
- Jennifer M. Gogley
- Observations
- 7
- Pages
- 7
- FEI number
- 2022073
In short: On March 26, 2019, FDA issued a Form 483 with 7 observations to McGuff Pharmaceuticals, Inc. in Santa Ana, California (FEI 2022073) after an inspection that ran Mar 18 – Mar 26, 2019. The investigator was Jennifer M. Gogley. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and…
- 03
Employees are not given training in the particular operations they perform as part of their function…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Jennifer M. Gogley
8 documents · 2007–2019
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McGuff Pharmaceuticals, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected McGuff Pharmaceuticals, Inc.?
Jennifer M. Gogley is named on this Form 483, for the inspection of Mar 18 – Mar 26, 2019. Each investigator has a profile showing what they cite most.
When was McGuff Pharmaceuticals, Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 26, 2019, and the Form 483 is dated March 26, 2019.
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.