Frontida BioPharm, LLC
FDA inspection history across 2 sites, 2015 to 2023
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one close-out letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17One Form 483, one warning letter and one close-out letter, at Philadelphia, Pennsylvania and Exton, Pennsylvania.
- 2015The longest 483 on file: 10 observations over 9 pages at Philadelphia, Pennsylvania.
- 2023One Form 483, at Philadelphia, Pennsylvania.
Cited most
Across all Frontida BioPharm observations on file
- 21 CFR 314.81Other postmarketing reports3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.150(b)Distribution procedures1
- 21 CFR 211.165(f)Testing and release for distribution1
The complete Frontida BioPharm file.
All 4 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
Philadelphia, Pennsylvania
Two Form 483s and one close-out letter · 2015 to 2023 · 12 observations
Latest: Form 483, Dec 7, 2023 →Exton, Pennsylvania
One warning letter · 2016
Latest: Warning letter, Aug 15, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-07 | 483 Form 483 | Philadelphia, Pennsylvania | 2 | $99 |
| 2017-04-28 | Close-out Close-out letter | Philadelphia, Pennsylvania | — | $99 |
| 2016-08-15 | Warning letter Warning letter | Exton, Pennsylvania | — | $99 |
| 2015-07-17 | 483 Form 483 | Philadelphia, Pennsylvania | 10 | $99 |
Investigators on these documents
Anastasia M. Shields (1)Gayle S. Lawson (1)Lisa B. Orr (1)Sharon K. Thoma (1)
FEI number 2523348 · most recent document Dec 7, 2023
About Frontida BioPharm, LLC
How many FDA Form 483s has Frontida BioPharm, LLC received?
FDA Intel has 2 Form 483s on file for Frontida BioPharm, LLC; the most recent is dated Dec 7, 2023.
When was Frontida BioPharm, LLC last inspected by FDA?
The most recent FDA inspection document on file for Frontida BioPharm, LLC is a Form 483 dated Dec 7, 2023, for the site in Philadelphia, Pennsylvania.
What did FDA cite at Frontida BioPharm, LLC?
The regulations cited most in the observations on file for Frontida BioPharm, LLC are 21 CFR 314.81 (Other postmarketing reports), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.
Has Frontida BioPharm, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Frontida BioPharm, LLC; the most recent is dated Aug 15, 2016.