Drug factory · FDA FEI 2013342
GVS TM, Inc
1630 W Industrial Park Street, Covina, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 25, 2019.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 25, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 19, 2014 | No problems found | Drug Quality Assurance | — |
| Nov 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
| Mar 18, 2011 | No problems found | Drug Quality Assurance | — |
| Jun 25, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 15, 2018 inspection
- Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Nov 8, 2012 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - 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. - Data secured in course of each test 21 CFR 211.194(a)(4)
Laboratory records do not include a complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation, properly identified to show the drug product tested. - Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include parameters relevant to the operation. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jun 25, 2010 inspection
- Written record of investigation incomplete 21 CFR 211.192
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. - Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products. - Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
Registered with FDA for: label; manufacture.