Drug factory · FDA FEI 3006644152
Indoco Remedies Limited
Goa Plant-I, L-14, Verna Industrial Area, Verna, Goa, India
Problems found, fixed voluntarily at FDA's last inspection, Jan 20, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2015: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
| Jan 19, 2018 | Serious problems, FDA action | Drug Quality Assurance | 8 |
| Oct 29, 2015 | 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.
Jan 20, 2023 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
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. - Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written and followed. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that components, in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity. - Valid stability test methods 21 CFR 211.166(a)(3)
The written stability program for drug products does not include test methods. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review whether or not the batch has been already distributed. - 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. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education, training and experience required to perform their assigned functions. - 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. - 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.
Jan 19, 2018 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. - Sample size - test intervals 21 CFR 211.166(a)(1)
The written stability program for drug products does not include test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability. - Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - Labeling: documentation of exam and review 21 CFR 211.184(d)
There is no documentation of the examination and review of labels and labeling for conformity with established specifications. - Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing, packing and holding. - 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. Electronic records are used, but they do not meet requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - 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. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
Registered with FDA for: analysis; label; manufacture; pack.