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FDA establishment 2623619, Vega Baja, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.
Inspections: 10
Official action indicated: 0
Last inspection ended: May 18, 2026
Warning letters: 0
Import refusals since 2024: 2
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.56(a). Sanitation--buildings not clean, free of infestation Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
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 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
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.
Voluntary Action Indicated (VAI)
Feb 17, 2022
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
Voluntary Action Indicated (VAI)
Jan 26, 2018
Drugs · Drug Quality Assurance
1 cited reference
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Voluntary Action Indicated (VAI)
Jul 26, 2016
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
21 CFR 211.68(a). Calibration/Inspection/Checking not done Routine inspection and checking of electronic equipment is not performed according to a written program designed to assure proper performance.
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 211.160(a). Following/documenting laboratory controls Established test procedures are not followed.
Voluntary Action Indicated (VAI)
Jun 19, 2015
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Mar 11, 2014
Drugs · Drug Quality Assurance
2 cited references
21 CFR 211.192. Investigations of discrepancies, failures There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Voluntary Action Indicated (VAI)
Jul 16, 2013
Drugs · Drug Quality Assurance
4 cited references
21 CFR 211.160(b)(4). Establishment of calibration procedures Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
21 CFR 211.166(a)(1). Sample size - test intervals The written stability program for drug products does not include sample size based on statistical criteria for each attribute examined to assure valid estimates of stability.
21 CFR 211.100(b). SOPs not followed / documented Written production and process control procedures are not followed in the execution of production and process control functions.
21 CFR 211.166(a). Lack of written stability program There is no written testing program designed to assess the stability characteristics of drug products.
Voluntary Action Indicated (VAI)
Aug 10, 2012
Drugs · Drug Quality Assurance
None posted
Voluntary Action Indicated (VAI)
Jan 26, 2011
Drugs · Drug Quality Assurance
13 cited references
21 CFR 211.110(a). Written in-process control procedures Written procedures are not followed that describe the in-process controls and examinations to be conducted on appropriate samples of in-process materials of each batch.
21 CFR 211.113(a). Procedures for non-sterile drug products Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established and followed.
21 CFR 211.192. Extent of discrepancy, failure investigations Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product.
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 211.110(a). Control procedures to monitor and validate performance Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
21 CFR 211.80(b). Handling and Storage to Prevent Contamination There was a failure to handle and store drug product containers at all times in a manner to prevent contamination.
21 CFR 211.165(a). Testing and release for distribution Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 211.198(a). Complaint Handling Procedure Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
21 CFR 211.194(d). Laboratory equipment calibration records Laboratory records do not include complete records of the periodic calibration of laboratory instruments.
21 CFR 211.67(b). Written procedures not established/followed Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
21 CFR 211.80(a). Written Procedures Not Followed Written procedures are not followed for the storage and handling of components.
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.
Voluntary Action Indicated (VAI)
Mar 25, 2009
Drugs · Postmarket Surv. and EpidemiologyDrugs · Drug Quality Assurance
None posted
No Action Indicated (NAI)
Import Refusals
2 refused shipment lines since 2024, grouped by product and charges
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
Vega Baja, Puerto Rico, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.