US Specialty Formulations LLC
FDA inspection history across 2 sites, 2015 to 2026
- 8
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: one warning letter; 2024: one Form 483; 2025: two Form 483s; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Three Form 483s and one warning letter, at Bethlehem, Pennsylvania.
- 2022–26Five Form 483s and one warning letter, at Allentown, Pennsylvania.
- 2022The longest 483 on file: 17 observations over 17 pages at Allentown, Pennsylvania.
Cited most
Across all US Specialty Formulations observations on file
- 21 CFR 211.165Testing and release for distribution11
- 21 CFR 211.42(a)Design and construction features8
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.160General requirements5
- 21 CFR 211.166Stability testing4
The complete US Specialty Formulations file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
Allentown, Pennsylvania
Five Form 483s and one warning letter · 2022 to 2026 · 41 observations
Latest: Form 483, Jan 14, 2026 →Bethlehem, Pennsylvania
Three Form 483s and one warning letter · 2015 to 2019 · 30 observations
Latest: Form 483, Jul 23, 2019 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-14 | 483 Form 483 | Allentown, Pennsylvania | 7 | $99 |
| 2025-03-26 | 483 Form 483 | Allentown, Pennsylvania | 5 | $99 |
| 2025-03-26 | 483 Form 483 | Allentown, Pennsylvania | 5 | $99 |
| 2024-07-02 | 483 Form 483 | Allentown, Pennsylvania | 7 | $99 |
| 2023-07-26 | Warning letter Warning letter | Allentown, Pennsylvania | — | $99 |
| 2022-04-26 | 483 Form 483 | Allentown, Pennsylvania | 17 | $99 |
| 2019-07-23 | 483 Form 483 | Bethlehem, Pennsylvania | 11 | $99 |
| 2017-08-29 | 483 Form 483 | Bethlehem, Pennsylvania | 7 | $99 |
| 2016-09-30 | Warning letter Warning letter | Bethlehem, Pennsylvania | — | $99 |
| 2015-05-29 | 483 Form 483 | Bethlehem, Pennsylvania | 12 | $99 |
Investigators on these documents
Lu Chen (3)James M. Mason (2)Nabihah Amatullah (2)Christina K. Theodorou (2)John R. Tuohig (1)Lori M. Newman (1)Mindy M. Chou (1)Anita R. Michael (1)Ucheabuchi C. Chudi-Nwankwor (1)Craig D. Zagata (1)Edmund F. Mrak (1)John M. Mastalski (1)
FEI number 3010680515 · most recent document Jan 14, 2026
About US Specialty Formulations LLC
How many FDA Form 483s has US Specialty Formulations LLC received?
FDA Intel has 8 Form 483s on file for US Specialty Formulations LLC; the most recent is dated Jan 14, 2026.
When was US Specialty Formulations LLC last inspected by FDA?
The most recent FDA inspection document on file for US Specialty Formulations LLC is a Form 483 dated Jan 14, 2026, for the site in Allentown, Pennsylvania.
What did FDA cite at US Specialty Formulations LLC?
The regulations cited most in the observations on file for US Specialty Formulations LLC are 21 CFR 211.165 (Testing and release for distribution), 11 times; 21 CFR 211.42(a) (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 5 times.
Has US Specialty Formulations LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for US Specialty Formulations LLC; the most recent is dated Jul 26, 2023.