Sharp Clinical Services, LLC
FDA inspection history in Bethlehem, Pennsylvania, 2019 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Bethlehem, Pennsylvania.
- 2022One Form 483, at Bethlehem, Pennsylvania.
- 2022The longest 483 on file: 5 observations over 5 pages at Bethlehem, Pennsylvania.
Cited most
Across all Sharp Clinical Services observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.166Stability testing1
The complete Sharp Clinical Services 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
Bethlehem, Pennsylvania
Two Form 483s · 2019 to 2022 · 9 observations
Latest: Form 483, Sep 2, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-02 | 483 Form 483 | Bethlehem, Pennsylvania | 5 | $99 |
| 2019-08-30 | 483 Form 483 | Bethlehem, Pennsylvania | 4 | $99 |
Investigators on these documents
FEI number 3003673570 · most recent document Sep 2, 2022
About Sharp Clinical Services, LLC
How many FDA Form 483s has Sharp Clinical Services, LLC received?
FDA Intel has 2 Form 483s on file for Sharp Clinical Services, LLC; the most recent is dated Sep 2, 2022.
When was Sharp Clinical Services, LLC last inspected by FDA?
The most recent FDA inspection document on file for Sharp Clinical Services, LLC is a Form 483 dated Sep 2, 2022, for the site in Bethlehem, Pennsylvania.
What did FDA cite at Sharp Clinical Services, LLC?
The regulations cited most in the observations on file for Sharp Clinical Services, LLC are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.113 (Control of microbiological contamination), 1 time.