Precision Pharmacy Center LLC
Form 483 issued April 1, 2015 · Brea, California
- Inspection
- Mar 25 – Apr 1, 2015
- Investigator
- Thao T. Kwan
- Observations
- 6
- Pages
- 3
- FEI number
- 3011432609
In short: On April 1, 2015, FDA issued a Form 483 with 6 observations to Precision Pharmacy Center LLC in Brea, California (FEI 3011432609) after an inspection that ran Mar 25 – Apr 1, 2015. The investigator was Thao T. Kwan. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
4 of 6 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Thao T. Kwan
1 document · 2015
Cites 211.165(a) (testing and release for distribution) 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 211.165(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 6 observations on this Form 483, mostly about laboratory controls, production and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Precision Pharmacy Center LLC?
Thao T. Kwan is named on this Form 483, for the inspection of Mar 25 – Apr 1, 2015. Each investigator has a profile showing what they cite most.
When was Precision Pharmacy Center LLC inspected by FDA?
The inspection ran Mar 25 – Apr 1, 2015, and the Form 483 is dated April 1, 2015.
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.