# FDA 483 - Unichem Laboratories Limited - July 27, 2018

Source: https://www.keypedia.com/records/483/unichem-laboratories-limited/8e8f2c08-8db7-4a5f-aacc-e36154c8d7d1

> FDA 483 for Unichem Laboratories Limited on July 27, 2018. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Unichem Laboratories Limited
- Inspection Date: 2018-07-27
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: This FDA Form 483 documents observations from an inspection of Unichem Laboratories Ltd., an API manufacturer. The inspection revealed four key violations.

Firstly, cleaning procedures (PPQA029/04) for API manufacturing equipment are not validated to ensure product quality across multiple batch campaigns. The validation protocol lacked complete descriptions of equipment, procedures, materials, acceptable cleaning levels, parameters, and analytical methods. Additionally, the stability of the worst-case condition (a full campaign of (b)(4) batches) was undefined, despite finished API being distributed for years.

Secondly, test procedures for raw materials, intermediates, APIs, and labels are not scientifically sound. Specifically, finished product testing for (b)(4) USP Batch No. (b)(4) failed to correctly calculate and report Related Compound (b)(4), which was approximately 0.3% (OOS) but not investigated by Quality Assurance. Furthermore, procedure PPQC141/00 permits (b)(4) any blank response in HPLC analysis without confirming identity, investigation, or QA notification for potential OOS events.

Thirdly, laboratory controls for Media Preparation and Microbial Limits testing lack GMP compliance. Media are not quarantined pending growth promotion, and procedures do not require documentation of specific incubators or precise incubation times for microbial limits testing of raw materials, finished goods, or stability monitoring.

Finally, the stability program records for Batch No. lacked traceability for the materials of construction of

## Related Officers

- [William Leonard](https://www.keypedia.com/people/william-leonard/1f11ece4-597c-4d3e-aac4-46f8ea404ec3)

Company: https://www.keypedia.com/companies/unichem-laboratories-limited/322f49bb-81cf-4701-894c-ef740996d76b

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