# Choksi Laboratories Limited – FDA 483, Aug 20, 2026

Source: https://www.keypedia.com/records/483/choksi-laboratories-limited/ad27139b-b2b7-46be-8ab5-0b228a5b4c95

> FDA 483 for Choksi Laboratories Limited on August 20, 2026. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Choksi Laboratories Limited
- Inspection Date: 2026-08-20
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Choksi Laboratories Limited, a control testing laboratory in Indore, India, received a Form 483 with four observations indicating significant quality system deficiencies. The inspection revealed failures in thorough out-of-specification (OOS) investigations, lack of robust analytical methods, inadequate environmental controls and QC unit procedures, and routine delays in instrument calibration. Two of the observations were repeats from a previous 2019 inspection, suggesting persistent issues.

## Related Documents

- [483 - 2019-09-06](https://www.keypedia.com/records/483/choksi-laboratories-limited/a7901596-1627-4dec-af3c-10538d725cc2) — date: September 6, 2019
- [483 - 2018-04-25](https://www.keypedia.com/records/483/choksi-laboratories-limited/8d15e946-1b95-4570-9dd7-0b39fb7260f3) — date: April 25, 2018
- [483 - 2016-06-01](https://www.keypedia.com/records/483/choksi-laboratories-limited/b93da304-bd64-4971-b9c1-b719c54b43db) — date: June 1, 2016

## Related Officers

- [Pharmacy Intern/Certified Pharmacy Technician](https://www.keypedia.com/people/david-a-oluwo/209d60bd-27d8-487b-8249-1c6e44fcc317)

Company: https://www.keypedia.com/companies/choksi-laboratories-limited/9dd2f413-47cd-4d9e-916a-96a24127522c

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3