Drug factory · FDA FEI 2000046338
BioZone Laboratories, Inc
Pittsburg, California, United States
Matched to FDA's records by company name, because this plant's registration on the label has expired.
Problems found, fixed voluntarily at FDA's last inspection, Aug 9, 2013.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2009: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lidocaine | Makes it | Chadwick Pharmaceuticals, LLC | 70981-165 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 9, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 29, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jan 31, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 28, 2009 | Problems found, fixed voluntarily | 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.
Aug 9, 2013 inspection
- Establishment of time limitations 21 CFR 211.111
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Aug 29, 2012 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. - Written procedures not followed 21 CFR 211.122(a)
Written procedures for the receipt of packaging and labeling materials are not followed. - Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature and humidity so that their identity, strength, quality, and purity are not affected. - 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. - Review of representative number of batches 21 CFR 211.180(e)(1)
Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected. - Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete control and instructions. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, and packing of a drug product lack the training required to perform their assigned functions.