# FDA 483 - Alembic Pharmaceuticals Limited - March 20, 2018

Source: https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/a81be92f-aa80-44d2-a123-2cd68fca1582

> FDA 483 for Alembic Pharmaceuticals Limited on March 20, 2018. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alembic Pharmaceuticals Limited
- Inspection Date: 2018-03-20
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 details observations from an inspection, highlighting significant quality system and manufacturing deficiencies.

**Observation 1** cites a failure to thoroughly review unexplained discrepancies and Out-of-Specification (OOS) results. The firm exhibited high OOS invalidation rates: 94% in 2016 (131 of 140), 91% in 2017 (117 of 129), and 63% in early 2018 (19 of 30). Examples of invalidated OOS results lacking scientific rationale and supporting documentation include:
*   OOS #ALP/QA/OOS-8042 (high assay for Tablets USP mg): Attributed to sample preparation error, unsupported by re-injection/re-filled results.
*   OOS #ALP/QA/OOS-8027 (OOS impurity for Capsules USP mg): Attributed to glassware contamination, unsupported as all samples failed. Other contamination sources were not investigated.
*   OOS #ALP/QA/OOS-8058 (low assay for Tablets USP mg/ng): Attributed to sample preparation error, but repeat analysis deviated from the method, and preventative measures were inadequate.
*   OOS #ALP/QA/OOS-6491 (high assay for Tablets USP mg validation batch): Attributed to dilution error,

## Related Documents

- [483 - 2016-03-25](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/b5435c4b-1323-4172-9f87-3079d507645c)
- [483 - Unknown Date](https://www.keypedia.com/records/483/alembic-pharmaceuticals-limited/089e0b76-b314-449b-8ee8-280ef4484a66)

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.keypedia.com/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)

Company: https://www.keypedia.com/companies/alembic-pharmaceuticals-limited/922eba08-7d55-42d2-9d7e-d116c041af25

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c