McGuff Compounding Pharmacy Services, Inc.
Form 483 issued November 22, 2019 · Santa Ana, California
- Inspection
- Nov 12 – Nov 22, 2019
- Investigators
- Linda F. Murphy· Scott N. Lim
- Observations
- 7
- Pages
- 5
- FEI number
- 3005031360
In short: On November 22, 2019, FDA issued a Form 483 with 7 observations to McGuff Compounding Pharmacy Services, Inc. in Santa Ana, California (FEI 3005031360) after an inspection that ran Nov 12 – Nov 22, 2019. The investigators were Linda F. Murphy and Scott N. Lim. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.113 (3×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around…
- 02
HEPA filters were not sealed around each perimeter…
- 03
Your facility was designed and/or operated in a way that permits…
- 04
The use of sporicidal agents in the ISO 5 classified aseptic processing area…
This inspection in context
Linda F. Murphy
23 documents · 2015–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
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 211.113
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 7 observations on this Form 483, mostly about production, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected McGuff Compounding Pharmacy Services, Inc.?
Linda F. Murphy and Scott N. Lim are named on this Form 483, for the inspection of Nov 12 – Nov 22, 2019. Each investigator has a profile showing what they cite most.
When was McGuff Compounding Pharmacy Services, Inc. inspected by FDA?
The inspection ran Nov 12 – Nov 22, 2019, and the Form 483 is dated November 22, 2019.
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.