Rancho Park Compounding Pharmacy
Form 483 issued May 7, 2019 · Los Angeles, California
- Inspection
- Apr 23 – May 7, 2019
- Investigator
- Taichun Qin
- Observations
- 9
- Pages
- 7
- FEI number
- 3005199309
In short: On May 7, 2019, FDA issued a Form 483 with 9 observations to Rancho Park Compounding Pharmacy in Los Angeles, California (FEI 3005199309) after an inspection that ran Apr 23 – May 7, 2019. The investigator was Taichun Qin. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 9 of 9 observations.
Most cited: 21 CFR 211.42 (5×) · 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified aseptic processing areas had visibly dirt…
- 02
Non-microbial contamination was observed…
- 03
Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first…
- 04
Disinfecting agents and cleaning wipes used in the ISO 5 classified aseptic processing…
This inspection in context
Taichun Qin
35 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmRancho Park Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Rancho Park Compounding Pharmacy?
FDA listed 9 observations on this Form 483, mostly about 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 Rancho Park Compounding Pharmacy?
Taichun Qin is named on this Form 483, for the inspection of Apr 23 – May 7, 2019. Each investigator has a profile showing what they cite most.
When was Rancho Park Compounding Pharmacy inspected by FDA?
The inspection ran Apr 23 – May 7, 2019, and the Form 483 is dated May 7, 2019.
How do I get the full Form 483 for Rancho Park 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.