McGuff Compounding Pharmacy Services, Inc.
Form 483 issued December 31, 2014 · Santa Ana, California
- Inspection
- Dec 15 – Dec 31, 2014
- Investigators
- Caryn M. McNab· Sangeeta M. Khurana
- Observations
- 2
- Pages
- 2
- FEI number
- 3005031360
In short: On December 31, 2014, FDA issued a Form 483 with 2 observations to McGuff Compounding Pharmacy Services, Inc. in Santa Ana, California (FEI 3005031360) after an inspection that ran Dec 15 – Dec 31, 2014. The investigators were Caryn M. McNab and Sangeeta M. Khurana. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.167 (special testing requirements).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.167 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine…
- 02
There is no written testing program designed to assess the…
This inspection in context
Caryn M. McNab
7 documents · 2013–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMcGuff Compounding Pharmacy Services, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at McGuff Compounding Pharmacy Services, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.167 (special testing requirements). The opening words of each observation are shown on this page.
Who inspected McGuff Compounding Pharmacy Services, Inc.?
Caryn M. McNab and Sangeeta M. Khurana are named on this Form 483, for the inspection of Dec 15 – Dec 31, 2014. Each investigator has a profile showing what they cite most.
When was McGuff Compounding Pharmacy Services, Inc. inspected by FDA?
The inspection ran Dec 15 – Dec 31, 2014, and the Form 483 is dated December 31, 2014.
How do I get the full Form 483 for McGuff Compounding Pharmacy Services, 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.