Chen Shwezin Inc. dba Park Compounding Pharmacy
Form 483 issued April 3, 2018 · Westlake Village, California
- Inspection
- Mar 26 – Apr 3, 2018
- Investigator
- Nicholas L. Hunt
- Observations
- 5
- Pages
- 3
- FEI number
- 3005256616
In short: On April 3, 2018, FDA issued a Form 483 with 5 observations to Chen Shwezin Inc. dba Park Compounding Pharmacy in Westlake Village, California (FEI 3005256616) after an inspection that ran Mar 26 – Apr 3, 2018. The investigator was Nicholas L. Hunt. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent malfunctions and…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 04
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
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 211.165
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 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Chen Shwezin Inc. dba Park Compounding Pharmacy?
Nicholas L. Hunt is named on this Form 483, for the inspection of Mar 26 – Apr 3, 2018. 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 Mar 26 – Apr 3, 2018, and the Form 483 is dated April 3, 2018.
How do I get the full Form 483 for Chen Shwezin Inc. dba 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.