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Alcami Carolinas Corporation

FDA establishment 1000110990, Charleston, South Carolina, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 9
  • Official action indicated: 0
  • Last inspection ended: Feb 6, 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

9 inspections, newest first
EndedProduct and areaCitationsClassification
Feb 6, 2026Drugs · Drug Quality Assurance
6 cited references
  • 21 CFR 211.67(b). Written procedures fail to include Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used and instructions for removal or obliteration of previous batch identification.
  • 21 CFR 211.42(c)(10)(iv). Environmental Monitoring System Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
  • 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 followed.
  • 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 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
  • 21 CFR 211.110(c). In-process materials characteristics testing In-process materials are not tested for quality and approved or rejected by the quality control unit during the production process.
Voluntary Action Indicated (VAI)
Oct 29, 2021Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Mar 15, 2018Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Dec 15, 2017Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
May 16, 2016Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Dec 20, 2013Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
May 17, 2013Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)
Mar 23, 2012Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Jun 17, 2009Drugs · Drug Quality AssuranceNone postedNo Action Indicated (NAI)

Identifiers

FEI number
1000110990
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.