Leiter's Compounding Pharmacy
Form 483 issued December 19, 2018 · San Jose, California
- Inspection
- Dec 10 – Dec 19, 2018
- Investigator
- Ashar P. Parikh
- Observations
- 3
- Pages
- 2
- FEI number
- 3003434972
In short: On December 19, 2018, FDA issued a Form 483 with 3 observations to Leiter's Compounding Pharmacy in San Jose, California (FEI 3003434972) after an inspection that ran Dec 10 – Dec 19, 2018. The investigator was Ashar P. Parikh. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedmes applicable to the quality control unit are not in…
- 02
Employees engaged in the processing of a drug product lack the training required to…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Leiter's Compounding Pharmacy?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Leiter's Compounding Pharmacy?
Ashar P. Parikh is named on this Form 483, for the inspection of Dec 10 – Dec 19, 2018. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Dec 10 – Dec 19, 2018, and the Form 483 is dated December 19, 2018.
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.