Leiter's Compounding Pharmacy
Form 483 issued December 3, 2021 · San Jose, California
- Inspection
- Nov 16 – Dec 3, 2021
- Investigators
- Jolanna A. Norton· Lisa Shin
- Observations
- 4
- Pages
- 5
- FEI number
- 3003434972
In short: On December 3, 2021, FDA issued a Form 483 with 4 observations to Leiter's Compounding Pharmacy in San Jose, California (FEI 3003434972) after an inspection that ran Nov 16 – Dec 3, 2021. The investigators were Jolanna A. Norton and Lisa Shin. Most observations concern quality system and production.
At a glance
Quality system and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Leiter's Compounding Pharmacy?
Jolanna A. Norton and Lisa Shin are named on this Form 483, for the inspection of Nov 16 – Dec 3, 2021. Each investigator has a profile showing what they cite most.
When was Leiter's Compounding Pharmacy inspected by FDA?
The inspection ran Nov 16 – Dec 3, 2021, and the Form 483 is dated December 3, 2021.
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.