Directory › PolyPeptide
PolyPeptide — Torrance
Torrance, California, United States · CDMO
Site facts
- Company
- PolyPeptide
- Name(s) in FDA data
- PolyPeptide Laboratories, Inc.
- FEI number(s)
- 1000519239 (present in FDA Data Dashboard records for this name and city)
- Location (as in FDA data)
- Torrance, California, United States 90503
- Records matched
- 10 FDA inspections
- Most recent FDA inspection in dataset
- 10 May 2024 — VAI
Capabilities (from the company's website)
- Lyophilization
…intermediary processing laboratories, 7 purification suites, and several large scale tray lyophilization units. A state of the art QC lab has been established to support development and com…
- API / drug substance (chemical)
…he US FDA and other international regulatory bodies with approvals for over 10 commercial Active Pharmaceutical Ingredients. PolyPeptide San Diego, USA The San Diego, California site is a 45,000 square foot facil…
- Oral liquids & semi-solids
…peptides in milligram to gram quantities. The facility can also support production of isotopically labeled and radio-labeled peptides. The San Diego facility has been successfully inspec…
- Peptides & oligonucleotides
…PolyPeptide Torrance, USA The Torrance, California site is a 120,000 square foot (~12,000 sq. meters)…
- Formulation & process development
…s an area dedicated to development activities primarily to support GMP production through process development and process optimization. For GMP manufacturing, this facility supports 5 solid phase syn…
Taken from the company's web page for this site. Source: https://www.polypeptide.com/contacts/manufacturing-sites/san-diego-and-torrance-usa/, checked 16 Oct 2026. Quoted text shows the wording each tag is based on.
Regulatory timeline
Newest first. Each entry links to the published source. Inspection classifications: NAI = no action indicated, VAI = voluntary action indicated, OAI = official action indicated (FDA definitions). Posted 483 citations are FDA's short summaries, not the full Form 483.
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10 May 2024FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 1246171)
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19 Nov 2021FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 1159374)
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30 Aug 2019FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Veterinary. Project area(s): Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 1103072)
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19 Jul 2017FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 1021060)
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03 Dec 2015FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 953881)
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12 Apr 2013FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 827287)
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22 Feb 2012FDA inspection FDA inspection classified VAI
Voluntary Action Indicated (VAI). Product type(s): Drugs. Project area(s): Drug Quality Assurance.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 770485)
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07 Jul 2011FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 732994)
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13 Jan 2010FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 638781)
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27 Mar 2009FDA inspection FDA inspection classified NAI
No Action Indicated (NAI). Product type(s): Drugs, Veterinary. Project area(s): Drug Quality Assurance; Monitoring of Marketed Animal Drugs, Feed, and Devices.
Source: FDA Data Dashboard – Inspections (FEI 1000519239, inspection ID 573000)
This is a record of what regulators published, not a rating. Absence of a record here does not mean no record exists; see methodology for what we check and how records are matched.