PolyPeptide Group

Torrance, CA · Strasbourg, FR · Malmo, SE

Oligonucleotide

Program data pending ClinicalTrials.gov matching · Last scored 2026-04-29

65.1

Signal Score

✓ FDA Inspections (3) ○ Clinical Trials ○ SEC Filings ✓ Press (7) ○ EMA GMP ○ MHRA GMP

Quick Facts: PolyPeptide Group

Signal Score: 65.1/100 (as of 2026-04-29)
Quality Compliance: 71.5/100 — OAI classification at Winder (2025-08-05) — CRITICAL
Headquarters: Torrance, CA · Strasbourg, FR · Malmo, SE
Modalities: Oligonucleotide
Active Programs: No ClinicalTrials.gov matches confirmed
Data Sources: FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
Scored By: CDMO Signal — independent CDMO intelligence platform

Pure-play CDMO.

Quality Compliance

OAI classification at Winder (2025-08-05) — CRITICAL

FDA Inspections3 on record

Warning Letters0

Last InspectionOfficial Action Indicated (OAI) (2025-08-05)

OAI classification at Winder (2025-08-05) — CRITICAL

Operations —

No ClinicalTrials.gov facility matches confirmed for this manufacturer.

Programs — no verified data

Sponsors— no verified data

ModalitiesOligonucleotide

No clinical trial matches found for this manufacturer

Operational score requires ClinicalTrials.gov data

Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.

Financial Stability

Profile-based financial assessment

SEC FilingsPrivate company

Private company

Financial assessment: 61.0/100

Capacity

3 manufacturing sites

Recent Press7 articles

3 manufacturing sites

2025-08

2025-05

2025-02

NAI VAI OAI

Date	Site	Type	Observations	Classification
2025-08-05	Winder, Georgia	Drug Quality Assurance	Yes	Official Action Indicated (OAI)
2025-05-15	San Diego, California	Drug Quality Assurance	No	Voluntary Action Indicated (VAI)
2025-02-05	Winder, Georgia	Bioresearch Monitoring	No	No Action Indicated (NAI)

Source: FDA Data Dashboard · Retrieved May 20, 2026

Documentation & Records 5 (41.7%)
Other 2 (16.7%)
Laboratory Controls 2 (16.7%)
Equipment & Facilities 2 (16.7%)
CAPA 1 (8.3%)

Moderate (3) Laboratory Controls 2025-08-05 21 CFR 211.165(c)

Sampling and testing plans not followed

"Written procedures for sampling and testing plans are not followed for each drug product."
Moderate (3) Laboratory Controls 2025-08-05 21 CFR 211.166(a)

Results not used for expiration dates, storage cond.

"Results of stability testing are not used in determining expiration dates."
Moderate (3) CAPA 2025-08-05 21 CFR 211.188(b)(12)

Investigations made into any unexplained discrepancy

"Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed."