Sharp Services
United States
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (14)
○ Clinical Trials
○ SEC Filings
✓ Press (6)
○ EMA GMP
✓ MHRA GMP (2)
✓ HC GMP (19)
Quick Facts: Sharp Services
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- United States
- Website
- https://www.sharpservices.com/
- Modalities
- Packaging & Labeling, Sterile Fill-Finish
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About Sharp Services
Sharp Services is a contract development and manufacturing organization (CDMO). Capabilities: Packaging & Labeling, Sterile Fill-Finish. 3 manufacturing sites registered with the U.S. FDA, the UK MHRA and Health Canada. Website: https://www.sharpservices.com/
Signal Score
Profiled, not yet scored.
Scores are published after regulatory evidence is attached and reviewed.
How scoring works
Sharp Services FDA Inspection History
2026-04
2026-03
2026-02
2025-11
2025-09
2024-08
2024-06
2023-08
2023-02
2023-01
2022-12
2022-09
2022-01
2021-10
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-04-22 |
Sharp Packaging Services, LLC
Allentown, Pennsylvania
Company-level
|
Vaccines and Allergenic Products | No | No Action Indicated (NAI) |
| 2026-03-05 |
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts
Company-level
|
Drug Quality Assurance | Yes | Official Action Indicated (OAI) |
| 2026-02-06 |
Sharp Packaging Services, LLC
Conshohocken, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-11-21 |
Sharp Packaging Services, LLC
Allentown, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2025-09-12 |
Sharp Packaging Services, LLC
Macungie, Pennsylvania
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2024-08-29 |
Sharp Clinical Services, LLC
Bethlehem, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-06-12 |
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts
Company-level
|
Human Cellular, Tissue, and Gene Therapies | Yes | Voluntary Action Indicated (VAI) |
| 2023-08-25 |
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2023-02-24 |
Sharp Packaging Services, LLC
Conshohocken, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-01-20 |
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts
Company-level
|
Blood and Blood Products | No | Voluntary Action Indicated (VAI) |
| 2022-12-09 |
Sharp Packaging Services, LLC
Macungie, Pennsylvania
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2022-09-02 |
Sharp Clinical Services, LLC
Bethlehem, Pennsylvania
Company-level
|
Drug Quality Assurance | No | Voluntary Action Indicated (VAI) |
| 2022-01-28 |
Sharp Packaging Services, LLC
Allentown, Pennsylvania
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2021-10-15 |
Sharp Sterile Manufacturing, LLC
Lee, Massachusetts
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Nov 01, 2026
Sharp Services FDA 483 Findings 31 observations · 2021-10-15 → 2026-03-05 ?
By subsystem
By severity
- 4 — Serious: 2
- 3 — Moderate: 6
- 2 — Minor: 23
- Repeat observations: 3
Most severe findings
-
Cleaning System
"Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic conditions."
-
Cleaning System
"Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions."
-
Investigations of discrepancies, failures
"There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed."
Sharp Services MHRA GMP Compliance 2 certificates
2025-11
2025-11
Compliant
Non-Compliant
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK MIA 10284 Insp GMP/IMP 10284/18457585-0016[H] | SHARP CLINICAL SERVICES (UK) LIMITED | TREDEGAR NP22 5RL | 2025-11-04 | COMPLIANT |
| UK MIA(IMP) 10284 Insp GMP/IMP 10284/18457585-0016[I] | SHARP CLINICAL SERVICES (UK) LIMITED | TREDEGAR NP22 5RL | 2025-11-04 | COMPLIANT |
Source: MHRA GMDP Database · Retrieved Nov 01, 2026
Japan-accredited overseas site (PMDA)
cell and gene therapy (CGT), general (non-sterile), packaging/storage only, registration only · 4 sites
- Allentown, United States · Sharp Packaging Services, LLC — general (non-sterile), packaging/storage only · valid to Mar 30, 2030
- Bethlehem, United States · Sharp Clinical Services, LLC — registration only · valid to Nov 4, 2029
- Conshohocken, United States · Sharp Packaging Services, LLC — general (non-sterile) · valid to Dec 15, 2029
- Lee, United States · Sharp Sterile Manufacturing, LLC — cell and gene therapy (CGT) · valid to Jun 5, 2030
PMDA accreditation of a foreign manufacturing site is recognition within Japan's regulatory system, not an inspection outcome. PMDA's list covers only manufacturing sites outside Japan, so a company's plants in Japan are not on it. Source: PMDA, list of accredited/registered foreign manufacturers (as of Oct 16, 2026), Public Data License 1.0 (terms)
Hiring Activity 64 open roles Beta
From public job postings on Sharp Services' careers board, as of Oct 31, 2026. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
64
open roles
49
in manufacturing, quality, PD/MSAT, engineering or regulatory (77%)
Trend from Nov 29, 2026
Tracking started Oct 30, 2026. 30-day change shows after 30 days, 90-day after Jan 28, 2027.
Since Oct 30, 2026: 0 new postings, 0 taken down.
What this may mean
- 8 manufacturing and operations openings at Macungie. That fits staffing of production shifts; on its own it doesn't show new capacity.
By function
By site
Allentown
17 mfg/ops · 2 QA/QC · 4 eng. · 13 other 36
17 mfg/ops · 2 QA/QC · 4 eng. · 13 other 36
Macungie
8 mfg/ops · 2 QA/QC 10
8 mfg/ops · 2 QA/QC 10
Bethlehem
6 mfg/ops · 3 QA/QC 9
6 mfg/ops · 3 QA/QC 9
Conshohocken
4 mfg/ops · 1 QA/QC · 1 eng. · 2 other 8
4 mfg/ops · 1 QA/QC · 1 eng. · 2 other 8
Hamont Achel
· 1 eng. 1
· 1 eng. 1
Latest postings
Supply Chain Specialist
Manufacturing & operations · Conshohocken
Supervisor, Operations 3rd Shift
Manufacturing & operations · Macungie
Supervisor, Operations 1st Shift
Manufacturing & operations · Allentown
Supervisor, Operations
Manufacturing & operations · Conshohocken
Serialization and Electrical Engineer
Engineering & facilities · Allentown
Senior Validation Engineer
Quality (QA / QC) · Macungie
Senior Serialization and Technical Services Specialist
Other (finance, HR, IT, other) · Allentown
Senior Project Engineer
Engineering & facilities · Allentown
Senior Estimator
Other (finance, HR, IT, other) · Conshohocken
Quality Packaging Associate II, 2nd Shift
Manufacturing & operations · Allentown
Quality Packaging Associate II, 1st Shift
Manufacturing & operations · Allentown
Quality Assurance Specialist
Quality (QA / QC) · Bethlehem
Coverage: counted from Sharp Services' own careers board.
Function groups come mainly from job titles (about 84% match a hand check), and modality words from titles only, so both are approximate.
Source:
sharpservices.wd3.myworkdayjobs.com
· Checked Oct 31, 2026 · Tracking since Oct 30, 2026
Company Signals 6 articles
Company announcements, not verified evidence. They do not change any score.
Dr. Adriana Kiędzierska-Mencfeld Named Woman of the Year at CPHI Frankfurt - Contract Pharma
Lonza expects more CDMO contracts; Galderma’s $650M US commitment - Endpoints News
Sharp Sterile Manufacturing invests $28m into US sterile fill-finish site - Manufacturing Chemist
Sharp expands partnership with buyout of CDMO Berkshire Sterile Manufacturing - Fierce Pharma
Sharp Acquires Berkshire Sterile Manufacturing - BioPharm International
Sharp Services to Invest $100M Across Global Facility Network - Contract Pharma
Frequently Asked Questions About Sharp Services
How many FDA inspections does Sharp Services have on record?
CDMO Signal tracks 14 FDA inspections for Sharp Services, sourced from the FDA inspection database. See the full inspection history above.
Has Sharp Services received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Sharp Services.
Does Sharp Services hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 MHRA GMP certificates for Sharp Services.
Does Sharp Services have a CDMO Signal Score?
Not yet. Sharp Services is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
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