Leiter's Compounding Pharmacy
Form 483 issued March 6, 2014 · San Jo se, California
- Inspection
- Feb 18 – Mar 6, 2014
- Investigators
- Anh Lac· Henry K. Lau
- Observations
- 9
- Pages
- 5
- FEI number
- 3003434972
In short: On March 6, 2014, FDA issued a Form 483 with 9 observations to Leiter's Compounding Pharmacy in San Jo se, California (FEI 3003434972) after an inspection that ran Feb 18 – Mar 6, 2014. The investigators were Anh Lac and Henry K. Lau. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and production account for 8 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Written production and process control procedures are not followed in the execution of production…
- 04
Failure to reject any lot of components that did not meet the appropriate written specifications for…
This inspection in context
Anh Lac
13 documents · 2012–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmLeiter's Compounding Pharmacy history
All 15 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Leiter's Compounding Pharmacy?
FDA listed 9 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 Leiter's Compounding Pharmacy?
Anh Lac and Henry K. Lau are named on this Form 483, for the inspection of Feb 18 – Mar 6, 2014. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Feb 18 – Mar 6, 2014, and the Form 483 is dated March 6, 2014.
How do I get the full Form 483 for Leiter's 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.