Precision Pharmacy Center LLC
Form 483 issued June 17, 2016 · Brea, California
- Inspection
- Jun 3 – Jun 6, 2016
- Investigator
- Djamila Harouaka
- Observations
- 3
- Pages
- 2
- FEI number
- 3011432609
In short: On June 17, 2016, FDA issued a Form 483 with 3 observations to Precision Pharmacy Center LLC in Brea, California (FEI 3011432609) after an inspection that ran Jun 3 – Jun 6, 2016. The investigator was Djamila Harouaka. Most observations concern laboratory controls and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine…
- 02
There is no written testing program designed-to assess the stability characteristics of drug products. This…
- 03
Aseptic processing areas are deficient regarding the system…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmPrecision Pharmacy Center LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.167(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Precision Pharmacy Center LLC?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Precision Pharmacy Center LLC?
Djamila Harouaka is named on this Form 483, for the inspection of Jun 3 – Jun 6, 2016. Each investigator has a profile showing what they cite most.
When was Precision Pharmacy Center LLC inspected by FDA?
The inspection ran Jun 3 – Jun 6, 2016, and the Form 483 is dated June 17, 2016.
How do I get the full Form 483 for Precision Pharmacy Center LLC?
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.