Sklar BOV Solutions, Inc.
FDA inspection history across 2 sites, 2018 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2018: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Statesville, North Carolina.
- 2025One warning letter, at Vernon, California.
Cited most
Across all Sklar BOV Solutions observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22(a)Responsibilities of quality control unit2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.188(b)(11)Batch production and control records1
- 21 CFR 211.63Equipment design, size, and location1
The complete Sklar BOV Solutions 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
Vernon, California
One warning letter · 2025
Latest: Warning letter, Dec 9, 2025 →Statesville, North Carolina
One Form 483 · 2018 · 8 observations
Latest: Form 483, Mar 7, 2018 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-12-09 | Warning letter Warning letter | Vernon, California | — | $99 |
| 2018-03-07 | 483 Form 483 | Statesville, North Carolina | 8 | $99 |
Investigators on these documents
FEI number 3007953761 · most recent document Dec 9, 2025
About Sklar BOV Solutions, Inc.
How many FDA Form 483s has Sklar BOV Solutions, Inc. received?
FDA Intel has 1 Form 483 on file for Sklar BOV Solutions, Inc.; the most recent is dated Mar 7, 2018.
When was Sklar BOV Solutions, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Sklar BOV Solutions, Inc. is a Form 483 dated Mar 7, 2018, for the site in Statesville, North Carolina.
What did FDA cite at Sklar BOV Solutions, Inc.?
The regulations cited most in the observations on file for Sklar BOV Solutions, Inc. are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 2 times; 21 CFR 211.100(b) (Written procedures; deviations), 1 time.
Has Sklar BOV Solutions, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sklar BOV Solutions, Inc.; the most recent is dated Dec 9, 2025.