Sharp Sterile Manufacturing, LLC
FDA inspection history in Lee, Massachusetts, 2006 to 2024
- 8
- Form 483s
Every document, by year
- Form 483
2006: one Form 483; 2020: one Form 483; 2021: one Form 483; 2022: one Form 483; 2023: two Form 483s; 2024: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2006One Form 483, at Lee, Massachusetts.
- 2020–24Seven Form 483s, at Lee, Massachusetts.
- 2024The longest 483 on file: 8 observations over 7 pages at Lee, Massachusetts.
Cited most
Across all Sharp Sterile Manufacturing observations on file
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.192Production record review3
- 21 CFR 211.22(d)Responsibilities of quality control unit2
The complete Sharp Sterile Manufacturing file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Lee, Massachusetts
Eight Form 483s · 2006 to 2024 · 39 observations
Latest: Form 483, Oct 21, 2024 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-10-21 | 483 Form 483 | Lee, Massachusetts | 8 | $99 |
| 2024-06-12 | 483 Form 483 | Lee, Massachusetts | 4 | $99 |
| 2023-08-25 | 483 Form 483 | Lee, Massachusetts | 1 | $99 |
| 2023-01-20 | 483 Form 483 | Lee, Massachusetts | 6 | $99 |
| 2022-05-23 | 483 Form 483 | Lee, Massachusetts | 2 | $99 |
| 2021-10-15 | 483 Form 483 | Lee, Massachusetts | 6 | $99 |
| 2020-10-27 | 483 Form 483 | Lee, Massachusetts | 6 | $99 |
| 2006-01-01 | 483 Form 483 | Lee, Massachusetts | 6 | $99 |
Investigators on these documents
Erik W. Koester (2)Brentley Collins (1)Carl Perez (1)Daniel L. Zheng (1)Jie He (1)Jonathan G. Matrisciano (1)Latorie S. Jones (1)Mindy M. Chou (1)Obinna Echcozo (1)Sony Mathews (1)Andrea Franco (1)Syeda N. Mahazabin (1)
FEI number 3012144557 · most recent document Oct 21, 2024
About Sharp Sterile Manufacturing, LLC
How many FDA Form 483s has Sharp Sterile Manufacturing, LLC received?
FDA Intel has 8 Form 483s on file for Sharp Sterile Manufacturing, LLC; the most recent is dated Oct 21, 2024.
When was Sharp Sterile Manufacturing, LLC last inspected by FDA?
The most recent FDA inspection document on file for Sharp Sterile Manufacturing, LLC is a Form 483 dated Oct 21, 2024, for the site in Lee, Massachusetts.
What did FDA cite at Sharp Sterile Manufacturing, LLC?
The regulations cited most in the observations on file for Sharp Sterile Manufacturing, LLC are 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.100 (Written procedures; deviations), 6 times; 21 CFR 211.42 (Design and construction features), 4 times.