1Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Inspection Record
Gascó Industrial Corporation — FDA 483 Findings
Inspectors Jose F Velez · Ivis L Negron TorresThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions, schedules, limits for accuracy and precision and provisions for remedial action if limits are not met.
3Laboratory and QC controls
Drug products failing to meet established standards, specifications and quality control criteria are not rejected.
4Labeling and packaging
Reserve drug product samples are not appropriately identified, representative of each lot or batch of drug product and retained and stored under conditions consistent with product labeling.
5Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards of identity, strength, quality and purity.
6Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
7Equipment and facility
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
8Material and supplier control
The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.
9Laboratory and QC controls
Laboratory records are deficient in that they do not include the initials and signature of the second person reviewing the record for accuracy.
10Contamination control
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed.
11Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
12Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
13Complaint and recall handling
Complaint records are deficient in that they do not include the findings of the investigation and follow- up.
About this record
Extracted automatically from the document US FDA published on 2026-07-28. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
