Sharp Clinical Services, LLC
Form 483 issued September 2, 2022 · Bethlehem, Pennsylvania
- Inspection
- Aug 29 – Sep 2, 2022
- Investigators
- Terry Bridgewater· William Leonard
- Observations
- 5
- Pages
- 5
- FEI number
- 3003673570
In short: On September 2, 2022, FDA issued a Form 483 with 5 observations to Sharp Clinical Services, LLC in Bethlehem, Pennsylvania (FEI 3003673570) after an inspection that ran Aug 29 – Sep 2, 2022. The investigators were Terry Bridgewater and William Leonard. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and quality system account for 3 of 5 observations.
Most cited: 21 CFR 211.110 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
In-process materials are not tested for identity, strength, quality and purity and approved or rejected by…
- 02
The responsibilities and procedures applicable to the quality control unit are not in writing and…
- 03
An adequate number of batches of each drug product are not tested to determine…
- 04
Written procedures are not established that describe the in-process controls to be conducted on appropriate samples…
This inspection in context
Terry Bridgewater
4 documents · 2022–2023
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sharp Clinical Services, LLC?
FDA listed 5 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Sharp Clinical Services, LLC?
Terry Bridgewater and William Leonard are named on this Form 483, for the inspection of Aug 29 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was Sharp Clinical Services, LLC inspected by FDA?
The inspection ran Aug 29 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
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.