Drug factory · FDA FEI 3007187282
Panacea Biotec Pharma Limited
Pharma Block, Malpur, Baddi, Solan, India
Serious problems, FDA action at FDA's last inspection, Oct 12, 2023.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
9 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 3 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azacitidine | Makes it | Panacea Biotec Limited | 43817-906 |
| Prasugrel | Makes it | Apotex Corp., Panacea Biotec Limited | 60505-4642, 60505-4643, 60505-4856 +2 |
| Rizatriptan | Makes it | Bionpharma Inc., Panacea Biotec Limited | 69452-156, 69452-157, 43817-133 +1 |
| Tacrolimus | Makes it | Jubilant Cadista Pharmaceuticals Inc., Panacea Biotec Limited | 59746-798, 59746-799, 59746-800 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 12, 2023 | Serious problems, FDA action | Drug Quality Assurance | 9 |
| Jun 8, 2022 | Serious problems, FDA action | Drug Quality Assurance | — |
| Feb 20, 2020 | Serious problems, FDA action | Drug Quality Assurance | 7 |
| Apr 30, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 13, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 25, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 7, 2012 | No problems found | Drug Quality Assurance | — |
| Nov 13, 2009 | No problems found | 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.
Oct 12, 2023 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. - Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. - Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and 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 and the failure of a batch or any of its components to meet any of its specifications 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 and processing of a drug product lack the training required to perform their assigned functions. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - 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 and suitably located to facilitate operations for its intended use and cleaning and maintenance. - Cleaning SOPs/instructions 21 CFR 211.67(b)(3)
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
Feb 20, 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. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - 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. - Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
Test procedures relative to appropriate laboratory testing for sterility and pyrogens are not written. - 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. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; manufacture.