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Liebel-Flarsheim Company LLC

FDA establishment 1028892, Raleigh, North Carolina, United States. Part of Liebel-Flarsheim Company's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 7
  • Official action indicated: 1
  • Last inspection ended: Apr 8, 2025
  • Warning letters: 1

Inspections by Fiscal Year

FY2018 to FY2027 to date; 1 classified OAI

Most Cited at This Site

Inspections citing each reference

Inspections

7 inspections, newest first
EndedProduct and areaCitationsClassification
Apr 8, 2025Drugs · Drug Quality Assurance
5 cited references
  • 21 CFR 211.58. Buildings not maintained in good state of repair Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
  • 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies do not include the conclusions and follow-up.
  • 21 CFR 211.25(a). Training , Education , Experience overall Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
  • 21 CFR 211.42(c)(10)(i). Floors, walls, ceiling surfaces Aseptic processing areas are deficient in that floors are not smooth and/or hard surfaces that are easily cleanable.
  • 21 CFR 211.160(b). Scientifically sound laboratory controls Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Official Action Indicated (OAI)
Aug 31, 2018Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Jul 29, 2016Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Jul 25, 2014Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
May 4, 2012Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Aug 20, 2010Drugs · Drug Quality Assurance
3 cited references
  • 21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store closures at all times in a manner to prevent contamination.
  • 21 CFR 211.192. Written record of investigation incomplete Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
  • 21 CFR 211.113(b). Procedures for sterile drug products Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
Voluntary Action Indicated (VAI)
Mar 5, 2010Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices; Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)

Warning Letters

Letters naming this establishment; each opens the letter

Identifiers

FEI number
1028892
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.