Central Admixture Pharmacy Services, Inc. (CAPS)
Form 483 issued August 25, 2023 · San Diego, California
- Inspection
- Jul 10 – Aug 25, 2023
- Investigators
- Doan N. Singh· Jolanna A. Norton· Rachel C. Stanton
- Observations
- 17
- Pages
- 28
- FEI number
- 3004378804
In short: On August 25, 2023, FDA issued a Form 483 with 17 observations to Central Admixture Pharmacy Services, Inc. (CAPS) in San Diego, California (FEI 3004378804) after an inspection that ran Jul 10 – Aug 25, 2023. The investigators were Doan N. Singh, Jolanna A. Norton, Rachel C. Stanton and Xiaohui Shen. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedmes applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Procedures describing the handling of written and oral complaints related to drug products are not written…
This inspection in context
Doan N. Singh
2 documents · 2010–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmCentral Admixture Pharmacy Services, Inc. (CAPS) history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services, Inc. (CAPS)?
FDA listed 17 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc. (CAPS)?
Doan N. Singh, Jolanna A. Norton, Rachel C. Stanton and Xiaohui Shen are named on this Form 483, for the inspection of Jul 10 – Aug 25, 2023. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. (CAPS) inspected by FDA?
The inspection ran Jul 10 – Aug 25, 2023, and the Form 483 is dated August 25, 2023.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc. (CAPS)?
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.