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Auro PR Inc

FDA establishment 2650176, Caguas, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.

  • Inspections: 9
  • Official action indicated: 2
  • Last inspection ended: May 31, 2023
  • 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
May 31, 2023Drugs · Drug Quality Assurance
2 cited references
  • 21 CFR 211.165(b). Microbiological testing Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
  • 21 CFR 211.166(a)(4). Testing in same container - closure system The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.
Voluntary Action Indicated (VAI)
Mar 15, 2018Drugs · Drug Quality Assurance
4 cited references
  • 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 211.160(b)(4). Calibration - at intervals, written program, remedial action The calibration of instruments is not done at suitable intervals with provisions for remedial action in the event accuracy and/or precision limits are not met.
  • 21 CFR 211.82(a). Examination on receipt, before acceptance Each container or grouping of containers of components is not examined visually upon receipt and before acceptance for container damage.
  • 21 CFR 211.67(b)(3). Cleaning SOPs/instructions Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Voluntary Action Indicated (VAI)
Oct 24, 2016Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
May 22, 2015Drugs · Drug Quality Assurance
1 cited reference
  • 21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drug product.
Voluntary Action Indicated (VAI)
Apr 24, 2013Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Jun 7, 2012Drugs · Drug Quality AssuranceNone postedOfficial Action Indicated (OAI)
Feb 24, 2011Drugs · Drug Quality AssuranceNone postedOfficial Action Indicated (OAI)
Mar 29, 2010Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)
Feb 27, 2009Drugs · Drug Quality AssuranceNone postedVoluntary Action Indicated (VAI)

Identifiers

FEI number
2650176
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.