San Diego Compounding Pharmacy
Form 483 issued November 15, 2016 · San Diego, California
- Inspection
- Oct 17 – Nov 15, 2016
- Investigator
- Joey V. Quitania
- Observations
- 3
- Pages
- 1
- FEI number
- 3006072852
In short: On November 15, 2016, FDA issued a Form 483 with 3 observations to San Diego Compounding Pharmacy in San Diego, California (FEI 3006072852) after an inspection that ran Oct 17 – Nov 15, 2016. The investigator was Joey V. Quitania. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
TheKb) (4 ) I is not always conducted for each lot of sterile drug products. Sterile…
- 02
The firm has not demonstrated that the aseptic filling and closing operations are a dequate to…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmSan Diego Compounding Pharmacy 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 San Diego Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. 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 San Diego Compounding Pharmacy?
Joey V. Quitania is named on this Form 483, for the inspection of Oct 17 – Nov 15, 2016. Each investigator has a profile showing what they cite most.
When was San Diego Compounding Pharmacy inspected by FDA?
The inspection ran Oct 17 – Nov 15, 2016, and the Form 483 is dated November 15, 2016.
How do I get the full Form 483 for San Diego Compounding Pharmacy?
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.