# FDA 483 - Apothecon Pharmaceuticals Private Limited - May 01, 2026

Source: https://www.keypedia.com/records/483/apothecon-pharmaceuticals-private-limited/9244c0f3-beee-4299-9da3-3911cf4f098f

> FDA 483 for Apothecon Pharmaceuticals Private Limited on May 01, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Apothecon Pharmaceuticals Private Limited
- Inspection Date: 2026-05-01
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Apothecon Pharmaceuticals Pvt. Ltd. in Padra, Baroda, Gujarat, India, was cited for numerous deficiencies during an inspection of its drug substance and drug product manufacturing. Key issues include failures in data integrity, inadequate complaint handling, insufficient raw material testing, and scientifically unsound laboratory controls. The firm also demonstrated significant shortcomings in aseptic processing validation, cleaning and disinfection procedures, environmental monitoring, equipment maintenance, production controls, and the completeness of batch records, indicating a broad lack of adherence to cGMP requirements.

## Related Documents

- [483 - 2023-01-27](https://www.keypedia.com/records/483/apothecon-pharmaceuticals-private-limited/1ebb2750-95a4-453c-87de-3516afdb1d92)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [investigator](https://www.keypedia.com/people/chad-w-rice/b00f381a-744d-4e5e-90bf-07f60f494afc)

Company: https://www.keypedia.com/companies/apothecon-pharmaceuticals-private-limited/9fd69fd5-d0ef-458e-bdf3-b9b73b75f954

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8