Boiron Inc.
FDA inspection history across 2 sites, 2021 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2021: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–23One Form 483 and one warning letter, at Newtown Square, Pennsylvania and Newton Square, Pennsylvania.
Cited most
Across all Boiron observations on file
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.166(c)(1)Stability testing1
- 21 CFR 211.170(b)Reserve samples1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete Boiron 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
Newton Square, Pennsylvania
One warning letter · 2023
Latest: Warning letter, Sep 11, 2023 →Newtown Square, Pennsylvania
One Form 483 · 2021 · 5 observations
Latest: Form 483, Oct 25, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-11 | Warning letter Warning letter | Newton Square, Pennsylvania | — | $99 |
| 2021-10-25 | 483 Form 483 | Newtown Square, Pennsylvania | 5 | $99 |
Investigators on these documents
FEI number 2510831 · most recent document Sep 11, 2023
About Boiron Inc.
How many FDA Form 483s has Boiron Inc. received?
FDA Intel has 1 Form 483 on file for Boiron Inc.; the most recent is dated Oct 25, 2021.
When was Boiron Inc. last inspected by FDA?
The most recent FDA inspection document on file for Boiron Inc. is a Form 483 dated Oct 25, 2021, for the site in Newtown Square, Pennsylvania.
What did FDA cite at Boiron Inc.?
The regulations cited most in the observations on file for Boiron Inc. are 21 CFR 211.165(a) (Testing and release for distribution), 1 time; 21 CFR 211.166(c)(1) (Stability testing), 1 time; 21 CFR 211.170(b) (Reserve samples), 1 time.
Has Boiron Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Boiron Inc.; the most recent is dated Sep 11, 2023.