Leiter's Compounding Pharmacy
Form 483 issued October 7, 2014 · San Jo se, California
- Inspection
- Sep 15 – Oct 7, 2014
- Investigators
- Alicia K. McKinsey· Anh Lac
- Observations
- 4
- Pages
- 4
- FEI number
- 3003434972
In short: On October 7, 2014, FDA issued a Form 483 with 4 observations to Leiter's Compounding Pharmacy in San Jo se, California (FEI 3003434972) after an inspection that ran Sep 15 – Oct 7, 2014. The investigators were Alicia K. McKinsey and Anh Lac. Most observations concern production and quality system.
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 03
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Alicia K. McKinsey
3 documents · 2014–2015
Cites 211.42(c)(10)(iv) (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 211.113(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 4 observations on this Form 483, mostly about production, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected Leiter's Compounding Pharmacy?
Alicia K. McKinsey and Anh Lac are named on this Form 483, for the inspection of Sep 15 – Oct 7, 2014. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Sep 15 – Oct 7, 2014, and the Form 483 is dated October 7, 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.