Pii

Hunt Valley, Maryland, United States
Sterile Fill-Finish Lyophilization Oral Solid Dose High-Potency APIs Softgels
Program data pending ClinicalTrials.gov matching
Profiled
Not yet scored
✓ FDA Inspections (4) ○ Clinical Trials ○ SEC Filings ✓ Press (10) ○ EMA GMP ✓ MHRA GMP (2)

Quick Facts: Pii

Signal Score
Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
Headquarters
Hunt Valley, Maryland, United States
Website
Modalities
Sterile Fill-Finish, Lyophilization, Oral Solid Dose, High-Potency APIs, Softgels
Active Programs
No ClinicalTrials.gov matches confirmed
Data Sources
FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring

About Pii

Pii is a contract development and manufacturing organization (CDMO). Capabilities: Sterile Fill-Finish, Lyophilization, Oral Solid Dose, High-Potency APIs, Softgels. 2 manufacturing sites registered with the U.S. FDA, Health Canada and the UK MHRA. Website: https://www.pharm-int.com/

Signal Score

Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works

Pii FDA Inspection History

2026-03
2024-12
2022-11
2022-11
NAI VAI OAI
Date Site Type Observations Classification
2026-03-06
Pharmaceutics International, Inc.
Cockeysville, Maryland Company-level
Drug Quality Assurance Yes Official Action Indicated (OAI)
2024-12-06
Pharmaceutics International Inc
Hunt Valley, Maryland Company-level
Drug Quality Assurance Yes Voluntary Action Indicated (VAI)
2022-11-14
Pharmaceutics International Inc
Hunt Valley, Maryland Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
2022-11-14
Pharmaceutics International, Inc.
Cockeysville, Maryland Company-level
Drug Quality Assurance No Voluntary Action Indicated (VAI)
Source: FDA Data Dashboard · Retrieved Oct 31, 2026

Pii FDA 483 Findings 13 observations · 2024-12-06 → 2026-03-06 ?

By subsystem

  • Equipment & Facilities 4 (30.8%)
  • Documentation & Records 3 (23.1%)
  • Environmental Monitoring 2 (15.4%)
  • CAPA 2 (15.4%)
  • Other 1 (7.7%)
  • Laboratory Controls 1 (7.7%)

By severity

  • 4 — Serious: 2
  • 3 — Moderate: 3
  • 2 — Minor: 8
  • Repeat observations: 0

Most severe findings

  • Serious (4) Environmental Monitoring 2026-03-06 21 CFR 211.42(c)(10)(v)
    Cleaning System

    "Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions."

  • Serious (4) Environmental Monitoring 2026-03-06 21 CFR 211.113(b)
    Validation lacking for sterile drug products

    "Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process."

  • Moderate (3) CAPA 2026-03-06 21 CFR 211.192
    Investigations of discrepancies, failures

    "There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed."

Pii MHRA GMP Compliance 2 certificates

2016-02
2016-02
Compliant Non-Compliant
Certificate Site City / Postcode Inspection Date Status
UK GMP 22917 Insp GMP 22917/8721389-0002[I] PHARMACEUTICS INTERNATIONAL INCORPORATED 21030 2016-02-22 COMPLIANT
UK GMP 22917 Insp GMP/IMP 22917/37149-0007[H] PHARMACEUTICS INTERNATIONAL INCORPORATED 21031 2016-02-22 COMPLIANT
Source: MHRA GMDP Database · Retrieved Oct 31, 2026

Hiring Activity Beta

Built from public job postings when a company's own roles can be read. Job postings are signals, not statements by the company; each one below links to the original. How we collect this
No hiring data yet. We haven't found a public jobs feed for this company.
Source: public careers pages · Checked Oct 30, 2026

Company Signals 10 articles

Company announcements, not verified evidence. They do not change any score.
news Wed, 23 Fe
John Fowler Joins Pharmaceutics International as CEO - citybiz
news Wed, 05 Fe
Jabil Completes Acquisition of Pharmaceutics International, Inc. - PharmTech.com
news Tue, 19 No
Pii Expands Prefilled Syringe Services with $3.6M Investment in Capacity and Technology Upgrades - Business Wire
news Tue, 15 Ja
Pharmaceutical Industry Veteran Dr. Kurt R. Nielsen to lead Pharmaceutics International, Inc. (Pii) - PR Newswire
news Tue, 06 Se
Pharmaceutics International, Inc. (Pii) Receives $93 Million In Growth Capital - PR Newswire
news Tue, 04 Fe
Jabil Acquires Pharmaceutics International, Inc. (Pii) - Business Wire
news Tue, 04 Fe
Manufacturing juggernaut Jabil establishes CDMO presence with M&A play - Fierce Pharma
news Tue, 04 Fe
Jabil Acquires Pharmaceutics International Inc. - Medical Product Outsourcing
news Tue, 04 Fe
Jabil Acquires Pii - Contract Pharma
news Mon, 01 Oc
Pii Announces Serialization Implementation and Readiness - Lelezard

Frequently Asked Questions About Pii

How many FDA inspections does Pii have on record?
CDMO Signal tracks 4 FDA inspections for Pii, sourced from the FDA inspection database. See the full inspection history above.
Has Pii received an FDA warning letter?
CDMO Signal has no FDA warning letters on record for Pii.
Does Pii hold EMA or MHRA GMP certificates?
CDMO Signal tracks 2 MHRA GMP certificates for Pii.
Does Pii have a CDMO Signal Score?
Not yet. Pii is profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed.
Evaluating Pii for a manufacturing program?
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