Professional Partners Inc./ Westcliff Compounding Pharmacy
Form 483 issued May 9, 2016 · Newport Beach, California
- Inspection
- Apr 20 – May 9, 2016
- Investigator
- Yasamin Ameri
- Observations
- 8
- Pages
- 4
- FEI number
- 3012266548
In short: On May 9, 2016, FDA issued a Form 483 with 8 observations to Professional Partners Inc./ Westcliff Compounding Pharmacy in Newport Beach, California (FEI 3012266548) after an inspection that ran Apr 20 – May 9, 2016. The investigator was Yasamin Ameri. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Yasamin Ameri
20 documents · 2015–2022
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in India.
The firmProfessional Partners Inc./ Westcliff Compounding Pharmacy history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.94(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Partners Inc./ Westcliff Compounding Pharmacy?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Professional Partners Inc./ Westcliff Compounding Pharmacy?
Yasamin Ameri is named on this Form 483, for the inspection of Apr 20 – May 9, 2016. Each investigator has a profile showing what they cite most.
When was Professional Partners Inc./ Westcliff Compounding Pharmacy inspected by FDA?
The inspection ran Apr 20 – May 9, 2016, and the Form 483 is dated May 9, 2016.
How do I get the full Form 483 for Professional Partners Inc./ Westcliff 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.