Drug factory · FDA FEI 3002704547

Viva Pharmaceutical Inc.

13880 Viking Place, Richmond, Canada

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Oct 25, 2024 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.
• Procedures not in writing, fully followed 21 CFR 211.22(d)
  The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
• 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.

Jan 10, 2020 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 in-process control procedures 21 CFR 211.110(a)
  Written procedures are not established that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
• 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.
• Test methods 21 CFR 211.165(e)
  The accuracy, specificity and reproducibility of test methods have not been documented.
• Results not used for expiration dates, storage cond. 21 CFR 211.166(a)
  Results of stability testing are not used in determining expiration dates.
• Retention time for some OTC drugs 21 CFR 211.170(b)(3)
  OTC drug product reserve samples exempt from bearing an expiration date are not retained for three years after the lot or batch of drug product is distributed.
• Items to cover on annual reviews 21 CFR 211.180(e)(2)
  Written procedures are not followed for evaluations done at least annually and including provisions for a review of complaints, recalls and returned or salvaged drug products.
• Master production and control records, procedure 21 CFR 211.186(a)
  The preparation of your master production and control records was not described in a written procedure.
• Suitability of testing methods verified 21 CFR 211.194(a)(2)
  The suitability of all testing methods is not verified under actual conditions of use.
• Test method modification records not maintained 21 CFR 211.194(b)
  Complete records are not maintained of any modification of an established method employed in testing.
• Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
  Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
• Written procedures fail to include 21 CFR 211.67(b)
  Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.
• input/output verification 21 CFR 211.68(b)
  Input to and output from the computer and records or data are not checked for accuracy.
• Written Procedures Not Followed 21 CFR 211.80(a)
  Written procedures are not followed for the approval of components.

Dec 1, 2017 inspection

• Expiration date lacking 21 CFR 211.137(a)
  Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
• Written distribution procedure 21 CFR 211.150
  Written distribution procedures are not established.
• Quality control unit review of records 21 CFR 211.192
  Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
• Second person sign off 21 CFR 211.194(a)(8)
  Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards.
• Complaints reviewed by Quality Control Unit 21 CFR 211.198(a)
  Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy.
• Authority lacking to review records, investigate errors 21 CFR 211.22(a)
  The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
• Training , Education , Experience overall 21 CFR 211.25(a)
  Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
• Released Drug Products Area 21 CFR 211.42(c)(8)
  Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.
• Written procedures not established/followed 21 CFR 211.67(b)
  Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Sep 29, 2011 inspection

• Records reviewed annually 21 CFR 211.180(e)
  Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.
• Buildings not maintained in good state of repair 21 CFR 211.58
  Buildings used in the holding of a drug product are not maintained in a good state of repair.
• Procedures To Be in Writing 21 CFR 211.80(a)
  Written procedures are lacking which describe in sufficient detail the approval and rejection of components, drug product containers, and closures.

Registered with FDA for: analysis; label; manufacture; pack.