FDA Office

USA

Office of Inspections and Investigations

View detailed information about Office of Inspections and Investigations, including compliance records, people, and regulatory data.

Office Profile

Comprehensive profile of Office of Inspections and Investigations, including its role, location, and regulatory activities.

People (1)

Jeffrey P. Raimondi

INVESTIGATOR

Records (20)

483 - Sichuan Huiyu Pharmaceutical Co., Ltd.

drugs • Unknown Date

483

483 - Bioreliance Ltd.

biologics • Unknown Date

483

483 - Veeda Clinical Research Pvt. Ltd.

drugs • Unknown Date

483

483 - Alembic Pharmaceuticals Limited

drugs • Unknown Date

483

483 - Japan Food Research Laboratories, Chitose Laboratory

biologics • Unknown Date

483

483 - Hetero Drugs Ltd. - Unit 1

drugs • February 14, 2020

483

483 - Indena S.p.A.

drugs • July 29, 2016

483

483 - ClinSync Clinical Research Pvt Ltd

drugs • January 10, 2020

483

483 - Zydus Pharmaceuticals Limited

drugs • September 28, 2026

483

483 - Strides Pharma Private Limited

drugs • September 11, 2026

483

483 - Apnar Pharma Private Limited

drugs • September 11, 2026

483

483 - Cohance Lifesciences Limited

drugs • September 4, 2026

483

483 - Nippon Kayaku Pharmatech Co., Ltd.

drugs • September 4, 2026

483

483 - Indoco Remedies Limited

drugs • September 4, 2026

483

483 - CMIC Pharma Science Co., Ltd.

drugs • September 3, 2026

483

483 - FUJIFILM Diosynth Biotechnologies UK Limited

drugs • September 1, 2026

483

483 - Chengdu Shengnuo Biopharm Co Ltd

drugs • August 27, 2026

483

483 - AGC WAKASA CHEMICALS CO., LTD.

drugs • August 21, 2026

483

483 - MSN Laboratories Private Limited

drugs • August 14, 2026

483

483 - Hetero Labs Limited (Unit V)

drugs • August 7, 2026

483

Showing 1 to 20 of 20 records

Guidance Documents (10)

Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Guidance for Industry

Guidance

Enforcement Policy to Delay Requirements to Submit International Mail Tracking Number and Mail Service Name Until May 1, 2027: Guidance for Industry: Guidance for Industry

Guidance

Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry

Guidance

Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry

Guidance

Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry

Guidance

FDA Inspections Operations Management Manual 2025

Guidance

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection: Guidance for Industry

Guidance

CPG Sec 555250 DRAFT: Major Food Allergen Labeling and Cross-contact

Guidance

Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C: Guidance for Industry and FDA Staff

Guidance

CPG Sec 570200 Aflatoxins in Brazil Nuts

Guidance

Office Information

Name

Office of Inspections and Investigations

Abbreviation

OII

Country

USA

Postal Code

20857

State/Province

Maryland

City

Rockville

Address

12420 Parklawn Drive

Office Website

Visit Website

ID: 7dd0b904-a3df-46bc-a7b2-70ddb6f809c8

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