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Explore essential insights on batch release processes to enhance compliance and quality. Dive into our article for practical guidance and best practices.

| TITLE/ COMPANY | Issue Date | Status | Details |
|---|---|---|---|
| The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. Charles River Laboratories, Inc. |
27 Mar 2026 | Normal | Justification: Calibration ensures test accuracy and compliance. Excerpt: A (b)(4) weight with a calibration due date of 03/12/2026 was observed... View Details |
| Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance. Eosera, Inc. |
20 Mar 2026 | Normal | Justification: Calibration Management ensures equipment function correctly, impacting product quality. Overdue calibration violates compliance and risks product efficacy. Excerpt: I observed that your firm had not calibrated the in-line (b) (4) used to test (b) (4) in the manufacture of OTC drug products. View Details |
| Records of the calibration checks of automatic, mechanical or electronic equipment, including computers or related systems are not maintained. COSMETIC LABORATORY INC |
10 Mar 2026 | Normal | Justification: Observation highlights deficiencies in Calibration Management; scales were not calibrated per SOP, affecting operation reliability. Excerpt: Your firm failed to perform calibrations of your firm’s weighing scales. On 03/09/2026, your firm was unable to provide evidence... View Details |
| Laboratory records are deficient in that they do not include the initials and signature of the second person Gasco Industrial Corp. |
27 Feb 2026 | Normal | Justification: Calibration discrepancies can affect product quality, revealing procedural gaps. Excerpt: Calibration record for pH meters not verified for accuracy during operation period. View Details |
| Written calibration procedures for instruments, apparatus, gauges, and recording devices are deficient Gasco Industrial Corp. |
27 Feb 2026 | Normal | Justification: Calibration Management is fundamentally related as the instruments were used without ensuring calibration, impacting measurement accuracy. Excerpt: Written calibration procedures do not include specific directions, schedules, limits for accuracy and precision. View Details |
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