Pii
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
- https://www.pharm-int.com/
- 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
Pii FDA Inspection History
| 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) |
Pii FDA 483 Findings 13 observations · 2024-12-06 → 2026-03-06 ?
By subsystem
By severity
- 4 — Serious: 2
- 3 — Moderate: 3
- 2 — Minor: 8
- Repeat observations: 0
Most severe findings
-
Cleaning System
"Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions."
-
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."
-
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
| 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 |