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TEVA Pharmaceuticals USA, Inc.

FDA establishment 2245641, Fairfield, New Jersey, United States. Part of Teva Pharmaceuticals USA's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 7
  • Official action indicated: 0
  • Last inspection ended: Jul 20, 2026
  • Warning letters: 0

Inspections by Fiscal Year

FY2018 to FY2027 to date; 0 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first
EndedProduct and areaCitationsClassification
Jul 20, 2026Drugs · Drug Quality Assurance
1 cited reference
  • 21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for strength, quality and purity and approved or rejected by the quality control unit after storage for long periods.
Voluntary Action Indicated (VAI)
Nov 10, 2022Drugs · Drug Quality Assurance
3 cited references
  • 21 CFR 211.63. Equipment Design, Size and Location Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
  • 21 CFR 211.100(b). Procedure Deviations Recorded and Justified Deviations from written production and process control procedures are not recorded and justified.
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Jan 11, 2018Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Feb 1, 2017Drugs · Drug Quality Assurance
3 cited references
  • 21 CFR 211.22(d). Procedures not in writing, fully followed The responsibilities and procedures applicable to the quality control unit are not fully followed.
  • 21 CFR 211.194(a). Complete test data included in records Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Nov 6, 2013Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Mar 30, 2012Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Mar 19, 2010Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)

Identifiers

FEI number
2245641
FDA firm profile
Data Dashboard

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.