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Batch Manufacturing
Analytics Overview
Analytics Overview
Recent Form 483s & Warning Letters
Top Investigators
Observations
| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product. BSO LLC |
03 Jul 2024 | Normal | Justification: The issue directly relates to how batches are managed during manufacturing stages, specifically the lack of established timing protocols. Excerpt: Your firm failed to establish a hold times between start of batch manufacturing and (b)(4) sterilization for Anastrozole. View Details |
| Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products Brassica Pharma Pvt Ltd |
19 Jan 2024 | Normal | Justification: The observation identifies gaps in documenting critical changes during batch manufacturing, implicating process management practices. Excerpt: There was no documentation that had been made at the time of when the barriers were removed, why they were removed... View Details |
| Components for drug product manufacturing are not weighed and measured Torrent Pharmaceuticals Limited |
11 Dec 2023 | Normal | Justification: Batch manufacturing was directly implicated in the observation, as it involves the critical step of documenting component quantities, an essential aspect of the batch processing and record-keeping. Excerpt: I observed on December 8, 2023 during the manufacturing run of (b)(4) for (b)(4) Capsules (b)mg, Batch # (b)(4), and reviewing of exhibit batch records for Batch # (b)(4) (b)(4) - (b)(4) mg) and (b)(4) (b)(4) (b)(4) mg) that you utilized a vessel of solution preparation (ID #TPL-ON-018) filled with (b)(4) solution to be used during the (b)(4) solution stage. However, the amount of the (b)(4) solution required is not listed and recorded in the batch manufacturing record (Form #FN.011.02-20.709E). View Details |
| Your firm failed to establish adequate written procedures for production and process controls Stokes Healthcare Inc. dba Epicur Pharma |
25 Oct 2023 | Normal | Justification: The problem extends to the batch manufacturing process, where products were released into the market without validated processes, which is a critical breach. Excerpt: Approximately (b) (4) lots of both Tacrolimus AQ and Fluorouracil were manufactured and released for commercial distribution without validation. View Details |
| Batch production and control records do not include complete information relating to the production and control of each batch. Fresenius Kabi Oncology Limited |
10 Oct 2023 | Normal | Justification: The repeated issue of undocumented interventions points to broader manufacturing process inadequacies. Excerpt: 12 interventions to clear a jammed vial at (b) (4) resulted in missing documentation. View Details |
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