Drug factory · FDA FEI 2627511
Fenwal International, Inc.
Rd 357, Km 0.8, Maricao, PR, United States
Serious problems, FDA action at FDA's last inspection, Sep 24, 2021.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
8 drug inspections on record since 2009: 1 with no problems, 4 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Anhydrous Citric Acid and Anhydrous Dextrose | Makes it | Fenwal, Inc. | 0942-9001 |
| Anhydrous Citric Acid and Anhydrous Dextrose and Phosphate Ion | Makes it | Fenwal, Inc. | 0942-9201, 0942-9202 |
| Anticoagulant Citrate Phosphate Dextrose (cpd) Solution and Adsol Preservation S | Makes it, tests it, packages it, labels it and sterilizes it | Fenwal, Inc. | 0942-6453, 0942-6459, 0942-6477 +11 |
| Anticoagulant Citrate Phosphate Dextrose Adenine (cpda-1) | Makes it, tests it, packages it, labels it and sterilizes it | Fenwal, Inc. | 0942-6312, 0942-6316, 0942-6322 +4 |
| Platelet Additive 3 | Makes it | Fenwal, Inc. | 0942-9601, 0942-9602, 0942-9603 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 24, 2021 | Serious problems, FDA action | Drug Quality Assurance | 4 |
| Aug 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 25, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 21, 2014 | No problems found | Drug Quality Assurance | — |
| Apr 25, 2013 | Serious problems, FDA action | Drug Quality Assurance | 7 |
| Feb 24, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 23, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 2, 2009 | Serious problems, FDA action | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 24, 2021 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which 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. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed. - Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up. - Complaint Investigation/Follow-Up Findings 21 CFR 211.198(b)(2)
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
Aug 22, 2017 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Mar 25, 2015 inspection
- Reserve samples identified, representative, stored 21 CFR 211.170(b)
Reserve drug product samples are not retained and stored under conditions consistent with product labeling. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Apr 25, 2013 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
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. - Procedures are written, and followed 21 CFR 211.130
Procedures designed to assure that correct labels, labeling, and packaging materials are used for drug products are not written and followed. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
Written procedures describing the handling of complaints do not include provisions for a determination as to the need for an investigation of any unexplained discrepancy and explaining the reasons for the failure of the batch or any of its components to meet specifications. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Written procedures not established/followed 21 CFR 211.67(b)
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. - Failure to meet specifications 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.