Southern California Compounding Pharmacy, LLC
Form 483 issued August 1, 2019 · San Diego, California
- Inspection
- Jul 8 – Aug 1, 2019
- Investigator
- Santiago Gallardo Johnson
- Observations
- 5
- Pages
- 2
- FEI number
- 3010006900
In short: On August 1, 2019, FDA issued a Form 483 with 5 observations to Southern California Compounding Pharmacy, LLC in San Diego, California (FEI 3010006900) after an inspection that ran Jul 8 – Aug 1, 2019. The investigator was Santiago Gallardo Johnson. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Personnel and environmental monitoring conducted within the ISO 5 Environments on a [(o) 14)…
- 02
Gowning and aseptic practices…
- 03
The firm's cleaning and disinfecting procedure in the aseptic…
- 04
Smoke study conducted on 6/21/2019 to determine unidirectional airflows in ISO…
This inspection in context
Santiago Gallardo Johnson
18 documents · 2017–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmSouthern California Compounding Pharmacy, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Southern California Compounding Pharmacy, LLC?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Southern California Compounding Pharmacy, LLC?
Santiago Gallardo Johnson is named on this Form 483, for the inspection of Jul 8 – Aug 1, 2019. Each investigator has a profile showing what they cite most.
When was Southern California Compounding Pharmacy, LLC inspected by FDA?
The inspection ran Jul 8 – Aug 1, 2019, and the Form 483 is dated August 1, 2019.
How do I get the full Form 483 for Southern California Compounding Pharmacy, LLC?
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.