Sharp Clinical Services, LLC
Form 483 issued August 30, 2019 · Bethlehem, Pennsylvania
- Inspection
- Aug 26 – Aug 30, 2019
- Investigator
- William Leonard
- Observations
- 4
- Pages
- 4
- FEI number
- 3003673570
In short: On August 30, 2019, FDA issued a Form 483 with 4 observations to Sharp Clinical Services, LLC in Bethlehem, Pennsylvania (FEI 3003673570) after an inspection that ran Aug 26 – Aug 30, 2019. The investigator was William Leonard. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 02
Established standards are not followed. Electronic records are used, but they do not meet requirements to…
- 03
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
William Leonard
17 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmSharp Clinical Services, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Clinical Services, LLC?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Sharp Clinical Services, LLC?
William Leonard is named on this Form 483, for the inspection of Aug 26 – Aug 30, 2019. Each investigator has a profile showing what they cite most.
When was Sharp Clinical Services, LLC inspected by FDA?
The inspection ran Aug 26 – Aug 30, 2019, and the Form 483 is dated August 30, 2019.
How do I get the full Form 483 for Sharp Clinical Services, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.