Chen Shwezin Inc. dba Park Compounding Pharmacy
Form 483 issued October 5, 2015 · Westlake Village, California
- Inspection
- Aug 31 – Sep 11, 2015
- Investigators
- Darren S. Brown· Liming Zhang
- Observations
- 10
- Pages
- 7
- FEI number
- 3005256616
In short: On October 5, 2015, FDA issued a Form 483 with 10 observations to Chen Shwezin Inc. dba Park Compounding Pharmacy in Westlake Village, California (FEI 3005256616) after an inspection that ran Aug 31 – Sep 11, 2015. The investigators were Darren S. Brown and Liming Zhang. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
6 of 10 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmChen Shwezin Inc. dba Park Compounding Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Chen Shwezin Inc. dba Park Compounding Pharmacy?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and packaging & labeling. 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 Chen Shwezin Inc. dba Park Compounding Pharmacy?
Darren S. Brown and Liming Zhang are named on this Form 483, for the inspection of Aug 31 – Sep 11, 2015. Each investigator has a profile showing what they cite most.
When was Chen Shwezin Inc. dba Park Compounding Pharmacy inspected by FDA?
The inspection ran Aug 31 – Sep 11, 2015, and the Form 483 is dated October 5, 2015.
How do I get the full Form 483 for Chen Shwezin Inc. dba Park Compounding Pharmacy?
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