Leading Pharma, LLC
FDA inspection history in Fairfield, New Jersey, 2016 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Fairfield, New Jersey.
- 2024One Form 483, at Fairfield, New Jersey.
- 2024The longest 483 on file: 5 observations over 6 pages at Fairfield, New Jersey.
Cited most
Across all Leading Pharma observations on file
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.192Production record review2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.110(c)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.160General requirements1
The complete Leading Pharma file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Fairfield, New Jersey
Two Form 483s · 2016 to 2024 · 8 observations
Latest: Form 483, Oct 21, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-21 | 483 Form 483 | Fairfield, New Jersey | 5 | $99 |
| 2016-02-29 | 483 Form 483 | Fairfield, New Jersey | 3 | $99 |
Investigators on these documents
FEI number 3001611969 · most recent document Oct 21, 2024
About Leading Pharma, LLC
How many FDA Form 483s has Leading Pharma, LLC received?
FDA Intel has 2 Form 483s on file for Leading Pharma, LLC; the most recent is dated Oct 21, 2024.
When was Leading Pharma, LLC last inspected by FDA?
The most recent FDA inspection document on file for Leading Pharma, LLC is a Form 483 dated Oct 21, 2024, for the site in Fairfield, New Jersey.
What did FDA cite at Leading Pharma, LLC?
The regulations cited most in the observations on file for Leading Pharma, LLC are 21 CFR 211.165 (Testing and release for distribution), 2 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.