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Cosway Company Inc

FDA establishment 2016689, Gardena, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 2
  • Official action indicated: 0
  • Last inspection ended: Nov 30, 2018
  • 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

2 inspections, newest first
EndedProduct and areaCitationsClassification
Nov 30, 2018Drugs · Drug Quality Assurance
6 cited references
  • 21 CFR 211.44. Adequate lighting not provided Adequate lighting is not provided in all areas.
  • 21 CFR 211.194(a)(4). Complete Test Data Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
  • 21 CFR 211.122(d). Label storage access limited to authorized personnel Access to the storage area for labels and labeling materials is not limited to authorized personnel.
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
  • 21 CFR 211.42(c)(7). Quarantined Drug Products Area Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.
  • 21 CFR 211.166(a). Written program not followed The written stability testing program is not followed.
Voluntary Action Indicated (VAI)
Oct 28, 2013Drugs · Drug Quality Assurance
3 cited references
  • 21 CFR 211.188. Prepared for each batch, include complete information Batch production and control records do not include complete information relating to the production and control of each batch.
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
  • 21 CFR 211.182. Written records kept in individual logs Written records of major equipment maintenance and use are not included in individual equipment logs.
Voluntary Action Indicated (VAI)

Identifiers

FEI number
2016689
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.