Drug factory · FDA FEI 2433032
Arzol Chemical Company
12 Norway Ave. #2, Keene, NH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 14, 2024.
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 2009: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrate Ion and Silver Cation | Makes it | Arzol Chemical Company | 12870-0001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jan 23, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 19, 2011 | Problems found, fixed voluntarily | Unapproved and Misbranded Drugs | 8 |
| Dec 19, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Jul 14, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 14, 2024 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish 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. - 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. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(3)
Establishment of the reliability of the supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Jan 25, 2016 inspection
- Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed . - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed . - Buildings of Suitable Size, Construction, Location 21 CFR 211.42(a)
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. - Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - 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. - Rotation of components/containers/closures 21 CFR 211.86
There is a lack of rotation so that the oldest approved stock of components is used first.
Dec 19, 2011 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. - 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. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in current good manufacturing practices and written procedures required by current good manufacturing practice regulations.
Jul 14, 2009 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. - Lack of written stability program 21 CFR 211.166(a)
There is no written testing program designed to assess the stability characteristics of drug products. - Items to cover on annual reviews 21 CFR 211.180(e)(2)
Written procedures are not established for evaluations done at least annually and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product. - Component Test Records 21 CFR 211.184(b)
The component records do not include the results of tests or examinations performed. - Identification of each component or in-process material 21 CFR 211.188(b)(3)
Batch production and control records do not include the specific identification of each batch of used for each batch of drug product produced.
Registered with FDA for: manufacture.